{
  "topic": {
    "stem": "EVOLOCUMAB_ASCVD_AUTO_2",
    "name": "Evolocumab in ASCVD secondary prevention",
    "ncts": [
      "NCT05284747",
      "NCT03689946",
      "NCT01652703",
      "NCT04665830",
      "NCT04992065",
      "NCT03626831",
      "NCT03060577",
      "NCT05976893"
    ],
    "drug_patterns": [
      "evolocumab"
    ],
    "condition_patterns": [
      "cardiovascular"
    ]
  },
  "trials": [
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT05284747",
        "aact_title": "EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction",
        "aact_acronym": "EVOLVE-MI",
        "start_date": "2022-10-26",
        "primary_completion_date": "2027-05-29",
        "aact_intvs": [
          "evolocumab",
          "routine lipid management"
        ],
        "aact_conditions": [
          "cardiovascular disease",
          "coronary revascularization",
          "myocardial infarction"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Total (first and subsequent) composite of myocardial infarction, ischemic stroke, any arterial revascularization procedure, and all-cause death",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03689946",
        "aact_title": "Effect of Evolocumab on Coronary Atherosclerosis",
        "aact_acronym": "",
        "start_date": "2019-03-19",
        "primary_completion_date": "2023-01-28",
        "aact_intvs": [
          "evolocumab",
          "18f-naf pet",
          "ccta"
        ],
        "aact_conditions": [
          "cardiovascular disease",
          "hyperlipidemia"
        ],
        "pmid": "40178463",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1016/j.jcmg.2025.01.005",
        "aact_per_arm_counts": {
          "BG000": 47
        },
        "aact_primary_outcome_measure": "Change in Noncalcified Coronary Artery Plaque Volume (NCPV)",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT01652703",
        "aact_title": "A Study to Evaluate Tolerability and Efficacy of Evolocumab (AMG 145) in Japanese Subjects",
        "aact_acronym": "AMG145",
        "start_date": "2012-07-10",
        "primary_completion_date": "2013-05-14",
        "aact_intvs": [
          "evolocumab",
          "placebo"
        ],
        "aact_conditions": [
          "hypercholesterolemia and high risk for cardiovascular events"
        ],
        "pmid": "28367845",
        "pubmed_year": 2017,
        "pubmed_doi": "10.1253/circj.CJ-16-1016",
        "aact_per_arm_counts": {
          "BG000": 52,
          "BG001": 50,
          "BG002": 49,
          "BG003": 52,
          "BG004": 51,
          "BG005": 53
        },
        "aact_primary_outcome_measure": "Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "0.0"
          ],
          [
            "OG001",
            "0.0"
          ],
          [
            "OG002",
            "66.0"
          ],
          [
            "OG003",
            "96.0"
          ],
          [
            "OG004",
            "80.4"
          ],
          [
            "OG005",
            "82.4"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": false,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04665830",
        "aact_title": "PCSK 9 Inhibition as Secondary Prevention in Renal Transplant Patients",
        "aact_acronym": "",
        "start_date": "2018-05-01",
        "primary_completion_date": "2020-05-01",
        "aact_intvs": [
          "evolocumab"
        ],
        "aact_conditions": [
          "kideny transplant recipients with high cardiovascular risk score"
        ],
        "pmid": null,
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Any major cardiovascular events",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT04992065",
        "aact_title": "A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease",
        "aact_acronym": "",
        "start_date": "2021-08-03",
        "primary_completion_date": "2022-04-26",
        "aact_intvs": [
          "nnc0385-0434 a 15 mg",
          "nnc0385-0434 a 40 mg",
          "placebo i a (for nnc0385-0434 a 15 mg)"
        ],
        "aact_conditions": [
          "atherosclerotic cardiovascular disease"
        ],
        "pmid": "38310920",
        "pubmed_year": 2024,
        "pubmed_doi": "10.1016/S2213-8587(23)00325-X",
        "aact_per_arm_counts": {
          "BG000": 53,
          "BG001": 53,
          "BG002": 53,
          "BG003": 54,
          "BG004": 54
        },
        "aact_primary_outcome_measure": "Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "82.0"
          ],
          [
            "OG001",
            "60.0"
          ],
          [
            "OG002",
            "65.0"
          ],
          [
            "OG003",
            "56.0"
          ],
          [
            "OG004",
            "81.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03626831",
        "aact_title": "Effect of Evolocumab on Vascular Function",
        "aact_acronym": "EVO",
        "start_date": "2019-04-04",
        "primary_completion_date": "2021-04-15",
        "aact_intvs": [
          "evolocumab prefilled syringe",
          "placebos"
        ],
        "aact_conditions": [
          "atherosclerotic cardiovascular disease"
        ],
        "pmid": "40813220",
        "pubmed_year": 2025,
        "pubmed_doi": "10.1016/j.jacl.2025.07.001",
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Percent change of FMD",
        "aact_outcome_count_rows": []
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": true,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT03060577",
        "aact_title": "An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol",
        "aact_acronym": "ORION-3",
        "start_date": "2017-04-27",
        "primary_completion_date": "2021-12-17",
        "aact_intvs": [
          "inclisiran",
          "evolocumab"
        ],
        "aact_conditions": [
          "atherosclerotic cardiovascular disease",
          "familial hypercholesterolemia",
          "symptomatic atherosclerosis"
        ],
        "pmid": "36620965",
        "pubmed_year": 2023,
        "pubmed_doi": "10.1016/S2213-8587(22)00353-9",
        "aact_per_arm_counts": {
          "BG000": 290,
          "BG001": 92
        },
        "aact_primary_outcome_measure": "Percentage Change in LDL-C From Baseline of the ORION-1 Study to Day 210 in ORION-3 (Inclisiran Arm)",
        "aact_outcome_count_rows": [
          [
            "OG000",
            "161.0"
          ],
          [
            "OG000",
            "99.0"
          ],
          [
            "OG000",
            "97.0"
          ],
          [
            "OG000",
            "122.0"
          ],
          [
            "OG000",
            "82.0"
          ],
          [
            "OG000",
            "175.0"
          ],
          [
            "OG000",
            "225.0"
          ],
          [
            "OG000",
            "265.0"
          ]
        ]
      }
    },
    {
      "gates": {
        "A_aact_exists": true,
        "B_drug_in_intvs": true,
        "C_condition_in_aact": true,
        "D_pmid_topic_match": true,
        "E_two_arms": false,
        "F_primary_outcome_known": true
      },
      "extracted": {
        "nct": "NCT05976893",
        "aact_title": "Study on the Composite Endpoint Event of PCSK9 Inhibitor in Patients With Very High Risk of ASCVD and Cancer",
        "aact_acronym": "",
        "start_date": "2023-08-01",
        "primary_completion_date": "2025-12-31",
        "aact_intvs": [
          "evolocumab",
          "statin"
        ],
        "aact_conditions": [
          "ascvd",
          "atherosclerotic cardiovascular disease",
          "cancer"
        ],
        "pmid": "37416519",
        "pubmed_year": 2023,
        "pubmed_doi": "10.26599/1671-5411.2023.06.001",
        "aact_per_arm_counts": {},
        "aact_primary_outcome_measure": "Major cardiovascular adverse events",
        "aact_outcome_count_rows": []
      }
    }
  ],
  "n_total": 8,
  "n_pass_all": 3,
  "verdict": "VIABLE",
  "pass_rate": 0.375
}