Computed from this object's own state — a structural condition is unmet. This is not a fixed disclaimer: the conditions below are each testable, and a build in which they are met renders READY.
Does low-dose colchicine reduce major cardiovascular events? The trials on this page do not answer one question: their registered primary outcomes differ by whole components and one of them is not a composite.
In this section: Registration and administrative information (PROSPERO field set) · What this object claims to contain
| Review title | Colchicine for cardiovascular prevention |
|---|---|
| Review question (PICO) | Does low-dose colchicine reduce major cardiovascular events? The trials on this page do not answer one question: their registered primary outcomes differ by whole components and one of them is not a composite. |
| Population | Adults with chronic coronary disease, recent ACS, or non-cardioembolic ischaemic stroke/TIA |
| Intervention | Low-dose colchicine (0.5 mg daily) |
| Comparator | Placebo or usual care |
| Background / rationale | Not recorded — this object holds no background field, and an introduction generated without one would be argument that no source in this review supports |
| Eligibility criteria | not recorded on the page this object was built from |
| Information sources | 0 source layers, listed on the Extraction tab |
| Search strategy | The executed strings, datetimes, filters and hit counts are on the Search tab |
| Study selection process | Not recorded — no screening record was recoverable from the page this object was extracted from, so who screened and how cannot be stated |
| Number of screeners | Not recorded — this object records no screener count |
| Data extraction items | Extracted per trial on this object: registry id; primary publication; arms; per-arm counts and the published effect; the randomised total, separately from the analysed denominator. Fields not listed here were not extracted. |
| Outcomes and prioritisation | Major adverse cardiovascular events, as each trial defines them |
| Risk of bias method | Not recorded — no per-domain RoB-2 assessment exists yet |
| Synthesis methods | Not recorded — no outcome on this object carries a pooled estimate, so no synthesis method was applied |
| Subgroup analyses | Not recorded — this object records no subgroup-analysis field at all, so whether any were prespecified is UNKNOWN -- which is not the same as none having been |
| Meta-bias assessment | Not recorded — no funnel, Egger or Peters value is held on this object, so no meta-bias assessment is claimed |
| Certainty assessment | Not recorded — no GRADE record was recoverable from the page this object was extracted from |
| Funding | Not recorded — no funding statement is recorded for this review |
| Competing interests | Not recorded — no declaration is recorded |
| Built | 2026-08-18T00:00Z |
| Schema | 2-authored-from-source |
not recorded on the page this object was built from
In this section: Extracted values, and where each came from · References · Included studies · Regulatory documents · Methods and guidance · Sources · Major adverse cardiovascular events, as each trial defines them · Major adverse cardiovascular events, as each trial defines them · What was measured · Pooled result · Contributing trials · Endpoint definitions, read from the registry · Named on this review, contributing nothing to its pool
One row per extracted value. Every row carries the value, the verbatim sentence it was read from, a resolvable link to the source, and whether the number was read or derived. Where any of those is absent the row says so rather than omitting the value.
| Trial / outcome | Value as extracted | Verbatim source sentence | Source links | Read or derived |
|---|---|---|---|---|
| COLCOT primary | HR 0.77 (95% CI 0.61 to 0.96) | no source sentence recorded — this value cannot be checked against a quoted line here | NCT02551094 · source | DERIVED by us from the review page's own embedded trial record READ from the page's embedded publishedHR/hrLCI/hrUCI for this trial, not recomputed. It is this review's record of the trial's published hazard ratio; it has NOT been checked against the trial's own results record except where noted. |
| CLEAR SYNERGY primary | HR 0.99 (95% CI 0.85 to 1.16) | no source sentence recorded — this value cannot be checked against a quoted line here | NCT03048825 · source | DERIVED by us from the review page's own embedded trial record READ from the page's embedded publishedHR/hrLCI/hrUCI for this trial, not recomputed. It is this review's record of the trial's published hazard ratio; it has NOT been checked against the trial's own results record except where noted. |
| CONVINCE primary | HR 0.84 (95% CI 0.68 to 1.05) | no source sentence recorded — this value cannot be checked against a quoted line here | NCT02898610 · source | DERIVED by us from the review page's own embedded trial record READ from the page's embedded publishedHR/hrLCI/hrUCI for this trial, not recomputed. It is this review's record of the trial's published hazard ratio; it has NOT been checked against the trial's own results record except where noted. |
| Layer | Source | How it was obtained |
|---|
| Comparator | placebo, except CONVINCE which is usual care |
|---|---|
| Estimand | time to first event — random-effects |
| Effect scale | reported on the log scale; nothing is pooled on this outcome |
What is confirmed, stated as prominently as what is wrong. (1) colcot's event counts are the registry's own, exactly: 131 of 2366 against 170 of 2379. (2) the trial identities are right, and the page deserves credit for something this corpus has got wrong elsewhere: LoDoCo2 and cops are Australian trials with no ClinicalTrials.gov registration, and the page carries them as 'ACTRN-LODOCO2' and 'actrn-cops' rather than inventing NCT numbers for them. On DOAC_CANCER_VTE the same situation produced a row keyed to an unrelated German trial. Here it did not. (3) the direction of the underlying question is not in doubt and this withdrawal does not touch it: colchicine reduced events in COLCOT, 0.77 (0.61 to 0.96), and in LoDoCo2, 0.69 (0.57 to 0.83). What it did not do is reduce them in the two largest and most recent trials -- CLEAR SYNERGY 0.99 (0.85 to 1.16) and CONVINCE 0.84 (0.68 to 1.05) -- and a two-trial pool that drops the null ones is the specific thing that cannot stand here. What this withdrawal does not establish: not that colchicine is ineffective, and not that no synthesis of these trials is possible. It establishes that this one averaged endpoints that differ by whole components, over a trial count the page states three different ways, to reach a number none of its own data produces. The replacement question is identified and deliberately not taken. The defensible synthesis is over the trials whose composites genuinely share components -- COLCOT, LoDoCo2 and CLEAR SYNERGY, excluding CONVINCE's stroke-recurrence outcome -- and its answer is already known to whoever would choose it, because it was computed while bounding the search above: 0.813 (0.645 to 1.024), which crosses no effect. That is exactly why the choice must not be made by the person WHO has seen it. Parked.
Major adverse cardiovascular events, as each trial defines them. k = 3.
This object was authored rather than converted, so the outcome name is not a machine concatenation of trial titles. It states the finding instead: there is no shared endpoint.
What each trial COUNTED, in its own registry record's words, before anything here was pooled. A sentence saying what HAPPENED is not a sentence saying what was COUNTED, and only the second one licenses a pool. Read from the registry on 2026-08-18. Follow the registration link to disagree with any row.
| Trial | Rank in its own trial | Registered outcome measure | Description, verbatim | Analysis set / window |
|---|---|---|---|---|
| COLCOT NCT02551094 | PRIMARY -- index 0 of this registration's primary outcome list | First Event of Cardiovascular Death, Resuscitated Cardiac Arrest, Acute Myocardial Infarction, Stroke, or Urgent Hospitalization for Angina Requiring Coronary Revascularization | The descriptive statistics are the number of participants having at least one of the composites of the primary endpoint. | From randomization to first event, assessed up to 3.5 years. Placebo-controlled: registry arms are 'colchicine' and 'colchicine placebo'. |
| CLEAR SYNERGY NCT03048825 | PRIMARY -- index 1 of this registration's primary outcome list | Composite of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization | The first occurrence of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization in the colchicine comparison | Through study completion, an estimated average of 3 years. This is A 2x2 factorial trial of colchicine and spironolactone: the registry declares four arms -- 'Colchicine + Spironolactone +/- SYNERGY Stent', 'Spironolactone +/- SYNERGY Stent', 'Colchicine +/- SYNERGY Stent', 'Placebo +/- SYNERGY Stent' -- and separate co-primary outcomes for the colchicine comparison and the spironolactone comparison. The record carries NO results section, so which arms a colchicine contrast pools cannot be checked against a declared comparison. |
| CONVINCE NCT02898610 | PRIMARY -- index 0 of this registration's primary outcome list | Recurrence of non-fatal ischemic stroke | Any recurrence of non-fatal ischemic stroke | Any time within 60 months. Not placebo-controlled: the registry arms are 'Colchicine treatment' and 'Usual Standard of care alone', so this is an open comparison against usual care while COLCOT and LoDoCo2 are placebo-controlled. |
Two of the five trials this page auto-includes carry no embedded data at all. LoDoCo2 and cops are Australian trials registered on anzctr, not on ClinicalTrials.gov, and the page names them 'ACTRN-LODOCO2' and 'ACTRN-COPS'. That is the correct behaviour and it is worth saying so: the alternative -- attaching a plausible NCT number to a trial that has none -- is exactly the defect found on DOAC_CANCER_VTE. LoDoCo2's result reaches this page only as a published-comparator benchmark entry, 0.69 (0.57 to 0.83); Cops's does not reach it at all.
| Trial | Why it contributes nothing | What the registry holds |
|---|---|---|
| LoDoCo2 ACTRN12614000093684 | no embedded per-trial record on this page; present only as a published-synthesis benchmark | per this page's own benchmark record: CV death, spontaneous MI, ischaemic stroke, or ischaemia-driven coronary revascularisation |
| COPS ACTRN-COPS | named in the page's include list and carries no data anywhere on it | — |
In this section: Major adverse cardiovascular events, as each trial defines them · Forest plot · Risk of bias · GOSH · Trial-sequential analysis · Meta-regression
Drawn from the same stored estimates the table above lists. Box area is proportional to inverse-variance weight.
x-axis range
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All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: c55639e9965c84e2), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — forest_fit.eps, 4 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — forest_fit.tiff, 12,129 KB.
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All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: 8024b2e0759bc94c), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — forest_w1.eps, 4 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — forest_w1.tiff, 12,129 KB.
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All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: cbd1d2b300928ab0), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — forest_w2.eps, 4 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — forest_w2.tiff, 12,129 KB.
Changing the range moves the axis window only. The guides stay labelled with the null and the extremes of the plotted intervals, so no plotted value and no printed number differs between these views — and that is checked at build time, not asserted. Ranges not offered because they would crop the data: 0.7 to 1.3.
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Only the vector format is offered for this figure, by choice: it is line art — discrete marks, glyphs and labels — which SVG reproduces exactly at any size, so a raster would add weight without adding fidelity. The build was able to rasterise; it was asked not to.
Not drawn, because there is nothing to draw it from.
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All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: dd33d4f986f7c7c5), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — gosh.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — gosh.tiff, 5,537 KB.
Deliberately not drawn. Every subset meta-analysis of 3 trials is 7 points; a cloud that small cannot show the multimodality GOSH exists to reveal, and a reader would take the picture as evidence of its absence.
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All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: 25ed9800fdf56614), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — tsa.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — tsa.tiff, 6,665 KB.
TSA boundaries depend entirely on a target information size that must be pre-specified. This review's protocol registers none, so any boundary drawn here would be a parameter chosen after seeing the data -- which is the practice TSA exists to protect against.
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All raster formats were generated at build time from the same SVG as the graphic above (SHA-256, first 16 hex characters: 2316b730fa24744e), at 600 dpi for a 6-inch print width, on a white ground. They are not screenshots of the page and do not change with the theme you are reading in.
Submission formats written to the figures directory, not embedded here because an uncompressed 600 dpi TIFF is tens of megabytes: EPS (vector, journal's first choice for line art) — bubble.eps, 2 KB; TIFF (uncompressed, 600 dpi -- journal fallback) — bubble.tiff, 5,537 KB.
The protocol pre-specifies no moderator, and at k = 3 a meta-regression would be fitted on 3 points. Not drawn rather than drawn with a caveat: a bubble plot invites reading a slope, and there is no slope here that any reader should read.
In this section: Summary of findings · Reproducibility artifact · Other recorded qualifications
| Outcome | k | Pooled effect | Certainty |
|---|---|---|---|
| Major adverse cardiovascular events, as each trial defines them | 3 | not pooled | See comment12 |
| Canonical object | — |
|---|---|
| Registered at | — — |
| Schema | 2-authored-from-source |
| Object last updated | 2026-08-18T00:00Z |
| Source object SHA-256, first 16 hex characters | 1227718677bc1250 |
| Page generated | 2026-08-28 07:27 UTC |
| Generator build | 59b484ca7. The standard this page was built to is NOT ESTABLISHED: this object carries no build_stamp, so the version above is the standard that exists now, not the one this page was built against. |
This page CANNOT be rebuilt from what is recorded here: no canonical object is recorded and no registered commit is recorded. Each figure on the Analysis tab downloads as an SVG carrying exactly the values shown.
Statements this review records about the limits of what it establishes, which are not shown elsewhere on this page. They are reproduced from the object verbatim and are not summarised.
| Components as the registry states them | cardiovascular death; Resuscitated cardiac arrest; acute myocardial infarction; stroke; Urgent hospitalization for angina requiring coronary revascularization. Five components. |
|---|---|
| Analysis set as the registry states it | From randomization to first event, assessed up to 3.5 years. Placebo-controlled: registry arms are 'colchicine' and 'colchicine placebo'. |
| Components as the registry states them | cardiovascular death; recurrent myocardial infarction; stroke; Unplanned ischemia-driven revascularization. Four components, and NO cardiac-arrest component. |
| Analysis set as the registry states it | Through study completion, an estimated average of 3 years. This is A 2x2 factorial trial of colchicine and spironolactone: the registry declares four arms -- 'Colchicine + Spironolactone +/- SYNERGY Stent', 'Spironolactone +/- SYNERGY Stent', 'Colchicine +/- SYNERGY Stent', 'Placebo +/- SYNERGY Stent' -- and separate co-primary outcomes for the colchicine comparison and the spironolactone comparison. The record carries NO results section, so which arms a colchicine contrast pools cannot be checked against a declared comparison. |
| Components as the registry states them | recurrence of non-fatal ischemic stroke, and nothing else. This registration declares three separate primary outcomes -- this one, 'non-fatal Major Cardiac event', and 'Vascular death' -- rather than one composite of them. |
| Analysis set as the registry states it | Any time within 60 months. Not placebo-controlled: the registry arms are 'Colchicine treatment' and 'Usual Standard of care alone', so this is an open comparison against usual care while COLCOT and LoDoCo2 are placebo-controlled. |
| The number was never this review s pool | It is an external published benchmark, and it says so in three places this page never consulted. `PUBLISHED_META_BENCHMARKS.json` records it under this page's filename as `benchmark type: self reference`, `source: COLCOT (Tardif JC, N Engl J Med 2019; 381:2497) + LoDoCo2 (Nidorf SM, N Engl J Med 2020; 383:1838)`, with both PMIDs and `method: DL random-effects pooling of 2 landmark RCTs`. `protocols/colchicine_cvd_protocol_v1.0_2026-04-19.md` names it as the published benchmark for the topic. `validate all apps.py` carries it as `{'hr': 0.75, ..., 'source': 'COLCOT+LoDoCo2 pooled', 'k': 2}`. The defect is not a wrong pool. It is a comparator rendered as a result -- the same shape as DOAC_AF, where the unreproducible headline turned out to be Ruff 2014's published risk ratio, which that page carries as its comparator. The number was real and belonged to somebody else. |
| And the benchmark does not reconcile with its own declared source | This is the second half and it is separate from the first. Taking the benchmark entirely at its word -- its two named trials and its declared DL random-effects method -- COLCOT `HR 0.77 (0.61 to 0.96)` and LoDoCo2 `HR 0.69 (0.57 to 0.83)` pool to **0.7215 (0.6243 to 0.8338)**, with Q below its degrees of freedom so DerSimonian-Laird sets tau-squared to zero and DL is the fixed-effect pool. The served upper bound is out by 0.0762 -- seven and a half units in the last quoted place. The benchmark's own declared participant total does not reconcile either: it states N = 11,816 where COLCOT (4,745) plus LoDoCo2 (5,522) is 10,267. |
| Proved by a bound not by a search | `scripts/pooled_point_in_achievable_range_gate.py`. Every inverse-variance pool, every Mantel-Haenszel and Peto pool and every fixed weighting is a convex combination of the per-trial log-effects, so a claimed point outside [min, max] cannot be produced by any estimator that has ever been written. Inside the hull the bound is the random-effects family itself: as tau-squared runs from 0 to infinity the weights run from the fixed-effect weights to equal weights, and the pooled point traces a path between the fixed-effect pool and the unweighted mean. COLCOT is the less precise of the two, so its weight can never exceed one half -- 40.7% at tau-squared 0, rising to 50% -- and reaching 0.745 would require it to carry seventy per cent. The achievable interval is 0.7215 to 0.7289. This is arithmetic, not an enumeration, and it covers estimators nobody has written yet. |
| The weaker result reported with its margin | Separately, no subset of any size of this page's four published hazard ratios -- COLCOT, CLEAR SYNERGY, CONVINCE, LoDoCo2 -- reproduces the served triple at any tau-squared under either a normal or a Knapp-Hartung interval. That result is thin and is not what closes this. Its nearest miss, LoDoCo2 with CONVINCE, is out by 0.0104 against a unit of 0.0100 in the last quoted place -- a margin of four per cent. It is recorded with that margin rather than stated as a verdict. It also cannot be the source: the benchmark names its two trials, and CONVINCE reported in 2024. |
| What this does not claim | Not that anyone fabricated a number. The provenance is now known and it is ordinary: a published benchmark was rendered in the slot a result belongs in. Not that the benchmark's underlying published figure is wrong -- only that it does not follow from the two trials and the one method this repository records beside it, and this repository has no other record of where it came . |
In this section: Paper · Title · Abstract · Introduction · Methods — eligibility criteria · Methods — outcomes sought at every registered rank · Results · Disagreements between sources · Limitations · Reporting guidelines · Note on registration · References · Figure legends · Figures · Trial characteristics · Notes on this record — sections not written, and why · Not reported in this record
Each statement below cites the record it came from; those sources are listed at the end of every section. Where the record holds nothing, the section says so by name rather than being left out, so a procedure that was not carried out can be told from one that simply was never mentioned.
Colchicine for cardiovascular prevention1
titleQuestion. Does low-dose colchicine reduce major cardiovascular events? The trials on this page do not answer one question: their registered primary outcomes differ by whole components and one of them is not a composite.1
questionBackground. This review asks: Does low-dose colchicine reduce major cardiovascular events? The trials on this page do not answer one question: their registered primary outcomes differ by whole components and one of them is not a composite. It examines 3 randomised trials and does not pool them, against placebo, except convince which is usual care. The outcome sought is Major adverse cardiovascular events, as each trial defines them.1
manuscript.introductionnot recorded on the page this object was built from1
screening.eligibilityEvery registered rank -- primary, secondary and other -- was read for 3 of 3 contributing trials before any decision about which outcomes could be combined; each records the time it was read.1
inputs.trials[].all_ranks_read_utcMajor adverse cardiovascular events, as each trial defines them. These 3 trials are not pooled, and the reason is stated rather than the outcome being quietly omitted: The trials do not share one endpoint, and one whole component is present in one and absent from the others. Colcot's registered primary, verbatim, is 'First Event of Cardiovascular Death, resuscitated cardiac arrest, Acute Myocardial Infarction, Stroke, or urgent hospitalization for angina requiring coronary revascularization' -- five components. Clear synergy's colchicine primary is 'Composite of cardiovascular death, recurrent myocardial infarction, stroke, or unplanned ischemia driven revascularization' -- four, with NO cardiac-arrest component and a different revascularisation trigger. LoDoCo2's, per this page's own benchmark record, is CV death, spontaneous myocardial infarction, ischaemic stroke, or ischaemia-driven coronary revascularisation. And convince is not a composite trial at all. Its registration declares three separate primary outcomes -- 'Recurrence of non-fatal ischemic stroke', 'non-fatal Major Cardiac event', and 'Vascular death' -- and the first of them counts recurrent non-fatal ischaemic stroke and nothing else. A single-component stroke-recurrence outcome cannot be averaged with a five-component cardiovascular composite. Separately: the page cannot agree with itself about how many trials this is. Its AUTO_INCLUDE_TRIAL_IDS names five -- colcot, LoDoCo2, cops, clear synergy and convince. Its embedded trial data carries three. The index card published k=2. Three different counts on one page, and nothing reconciles them. Separately again: the published number is not reconstructable. The card served 'HR 0.75 (0.61 to 0.91), k=2'. Thirty-three candidate pools were computed from this page's own four published hazard ratios -- every subset of two, three and four trials, under fixed-effect, DerSimonian-Laird and REML -- and none gives 0.75 (0.61 to 0.91). The closest, LoDoCo2 with convince under DerSimonian-Laird, gives 0.755 (0.623 to 0.915). Search bounded at 33 pools and reported as bounded. And whichever two trials it was, the pool excludes clear synergy in silence -- the largest trial here at 7,264 randomised, and the only one whose result is null at 0.99 (0.85 to 1.16). Nothing on the page states that it was left out.1
outcomes[id=primary].name, results.by_outcome.primary.pooled.withdrawn_reasonnot recorded on the page this object was built from1
not recorded on the page this object was built from2
reconciliation.why_this_step_existsreconciliation.clean_becauseEligible trials that do not contribute: Two of the five trials this page auto-includes carry no embedded data at all. LoDoCo2 and cops are Australian trials registered on anzctr, not on ClinicalTrials.gov, and the page names them 'ACTRN-LODOCO2' and 'ACTRN-COPS'. That is the correct behaviour and it is worth saying so: the alternative -- attaching a plausible NCT number to a trial that has none -- is exactly the defect found on DOAC_CANCER_VTE. LoDoCo2's result reaches this page only as a published-comparator benchmark entry, 0.69 (0.57 to 0.83); Cops's does not reach it at all.1
This review does not claim that the per-trial hazard ratios were checked against the journal reports; they were read from this review's own embedded data.2
1 claim(s) previously made about this review were corrected and the corrections are retained on the object rather than overwritten.3
What this review does not give a clinician: the number of events in each arm and any absolute effect or number needed to treat. A relative effect cannot be turned into the benefit or the risk facing one patient without them, so this review can support a judgement about what these trials found and not a judgement about what to do.4
eligible_but_not_contributing.noteverification_basis.what_is_not_claimedclaims_correctedresults.by_outcomeThis review reports against PRISMA 2020. A screening record is held on this object and the flow it supports is shown in the Methods. The completed PRISMA checklist and FLOW diagram are not held here: the venue requires them deposited in an approved repository with a DOI cited in the Data Availability Statement, and minting that DOI is an author action rather than a build step.1
screeningNo PROSPERO registration or protocol record is held on this object. That is not the same as knowing this review was not registered, and neither claim is made. It is recorded here as an absence so that a reader does not have to infer it from silence.1
bookkeeping_2026_08_21.whether_this_review_was_prospectively_registered| Trial | Registration | Registry | Read |
|---|---|---|---|
| NCT02551094 | ClinicalTrials.gov | ||
| NCT02898610 | ClinicalTrials.gov | ||
| NCT03048825 | ClinicalTrials.gov |
| Cited for | Reference |
|---|---|
| the reporting guideline this manuscript is written against | Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71 |
manuscript.referencesmanuscript.references| Outcome | Figure | What it shows |
|---|---|---|
| Major adverse cardiovascular events, as each trial defines them | Forest plot | not pooled; the reason is given in Results |
results.by_outcomeresults.by_outcome.primary.per_trial, results.by_outcome.primary.pooledresults.by_outcome.primary.per_trial, results.by_outcome.primary.pooled| Registration | Trial | Participants | Randomised | Primary outcome measured over | Design |
|---|---|---|---|---|---|
| NCT02551094 | COLCOT | not recorded | 4745 | From randomization to occurence of first event, assessed up to 3.5 years | colchicine (treatment, n=2366) vs colchicine placebo (control, n=2379) [+2 further fields recorded on the object] |
| NCT02898610 | CONVINCE | not recorded | 3154 | any time within 60 month; any time within 60 months; 60 months | Colchicine treatment (treatment, n=1569) vs Usual Standard of care alone (control, n=1575) [+2 further fields recorded on the object] |
| NCT03048825 | CLEAR SYNERGY | not recorded | 7264 | up to 1 year; through study completion, an estimated average of 3 years | Colchicine + Spironolactone +/- synergy Stent (treatment, n=3528) vs Placebo +/- synergy Stent (control, n=3534) [+2 further fields recorded on the object] |
inputs.trialsOf the four properties this project requires of a completed topic, 0 are held (none) and 4 are refused with the obstacle named in the evidence (the number of published syntheses this review was a GRADE certainty rating for each pooled outcome, the statistical model's output, quoted as it was produced, a risk-of-bias judgement for each reported result).1
bookkeeping_2026_08_21.which_limbs_this_review_refusesThe items below were not written because the record does not hold what they would be composed from. They are named here so that an absence is not mistaken for an omission.
| Article area | Item not reported | Reason |
|---|---|---|
| Abstract | The Background sentence of the abstract | Background is argument -- why this question matters -- and no arrangement of the quantities this object holds yields it. It is emitted only from an authored field and there is no composition path for it here |
| Abstract | The Methods sentence of the abstract | None of the method facts this would be composed from -- databases searched, eligibility, pooling model, risk-of-bias tool, certainty approach -- is recorded on this object |
| Abstract | The Results sentence of the abstract -- no outcome on this object carries a pooled point estimate, so there is nothing to report and none is manufactured here | The reason each pool is declined is given in Results |
| Abstract | The Conclusions sentence of the abstract | A conclusion is argument -- what a reader should now believe -- and it is emitted only from an authored field. Composing one from the estimate would be this renderer telling the reader what to conclude, which no field supports |
| Keywords | The keyword list | A content gap; no keywords are recorded and inventing them would be indexing this review under terms nobody chose |
| Methods — search | A database search for primary trials, which was not carried out for this review; the included trials were identified from named registrations | No further reason is recorded. |
| Methods — how many studies at each stage | The k cascade | No further reason is recorded. |
| Methods — synthesis | The model/estimator sentence for major adverse cardiovascular events, as each trial defines them | No pooled estimate was produced for this outcome, so no model was fitted and none is described |
| Methods — synthesis | The claim that records were screened in duplicate by two independent reviewers | No further reason is recorded. |
| Methods — synthesis | The claim that risk of bias was assessed with a named tool | No further reason is recorded. |
| Methods — synthesis | The claim that certainty of evidence was graded | No further reason is recorded. |
| Methods — synthesis | The claim that the review methods were prespecified before data collection | No further reason is recorded. |
| Risk of bias in the included results | The risk-of-bias assessment | No further reason is recorded. |
| Risk of bias in the included results | The risk-of-bias distribution | No further reason is recorded. |
| Certainty of the evidence | Certainty of the evidence, by outcome, with every rating step | No further reason is recorded. |
| Certainty of the evidence | The certainty assessment | No GRADE record is held, so the certainty column elsewhere on this page is an em dash rather than a guess |
| Discussion | The Discussion -- this is a content gap | The object records no interpretive text, and none is generated here: text written by the renderer would be an argument no field supports |
| Comparison with published syntheses | The comparison with published syntheses | No published synthesis is recorded for this topic, so no denominator can be given |
| Conclusions | The Conclusions -- this is a content gap | The object records no interpretive text, and none is generated here: text written by the renderer would be an argument no field supports |
| Data availability | The data availability statement | No further reason is recorded. |
| Software availability | The software and environment statement | No further reason is recorded. |
| Author contributions | The author-contributions statement | Who did what is a fact about people, and this object records none |
| Competing interests | The competing-interests declaration | F1000Research requires this section on every article, and requires explicit text where there is nothing to declare. It is a statement about the author and not about the evidence: no field of this object implies it and none is invented here |
| Grant information | The grant information | The venue requires each funder's name, the grant number where applicable, and the person the grant was assigned . None of that is derivable from a synthesis |
| Funding and conflicts of interest | The funding and conflict-of-interest statement -- a content gap | A submission requires it and this object does not carry it; it is not inferable from anything held here |
| Note on registration | The registration note | No further reason is recorded. |
| Registration | A registration statement: no prospective registration is recorded for this review, and whether one exists elsewhere has not been established | No further reason is recorded. |
| Extended data: statistical output, quoted verbatim | The verbatim model output | No analysis output is stored on this object, so nothing can be quoted and nothing is paraphrased in its place |
| Submission conformance | The submission conformance statement | No further reason is recorded. |
| Notes on this record — sections not written, and why | The list of refused properties | No further reason is recorded. |
UNSTAMPED — unknown-version. This page carries no build_stamp, so the standard it was built to cannot be established. That is a statement about the record, not a claim that the page is below standard.
Every number on this page is projected from a single canonical object, and each measured cell names the source analysis it was read from. That is what is machine-checked. It does not establish that the underlying sources are right, only that this page faithfully reports them.