{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:improve-it",
  "owner": "cardio",
  "kind": "study",
  "slug": "improve-it",
  "name": "IMPROVE-IT (ezetimibe added to simvastatin after acute coronary syndrome)",
  "aliases": [
    "IMPROVE-IT",
    "IMProved Reduction of Outcomes: Vytorin Efficacy International Trial"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial of 18,144 people who had recently been in hospital with an acute coronary syndrome. Everyone took the statin simvastatin, and half also took the cholesterol pill ezetimibe. Adding ezetimibe lowered LDL cholesterol further and gave a small extra reduction in heart and blood-vessel events over 7 years.",
  "summary_technical": "Phase 3, double-blind randomized trial (NCT00202878): simvastatin 40 mg with ezetimibe 10 mg against simvastatin 40 mg with placebo, 18,144 participants enrolled, 2005-10-17 to 2014-09-18. The abstract reports a 7-year Kaplan-Meier primary event rate of 32.7% against 34.7% (hazard ratio 0.936, 95% CI 0.89 to 0.99). The paper says the trial was funded by Merck; the registry now lists Organon and Co as lead sponsor. The registry names hypercholesterolemia and myocardial infarction as conditions.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT00202878",
      "normalized_value": "NCT00202878",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "condition-area": [
        "coronary-and-vascular-disease"
      ]
    }
  },
  "payload": {
    "design": "Allocation: randomized. Intervention model: parallel. Masking: triple. Primary purpose: treatment. (Registry values, in lower case.)",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct00202878-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2005-10-17",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct00202878-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2014-09-18",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct00202878-2026-10-14"
    },
    "completion_date": {
      "date": "2014-09-18",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct00202878-2026-10-14"
    },
    "results_first_posted": {
      "date": "2015-09-30",
      "type": null,
      "snapshot": "cardio:ctgov-nct00202878-2026-10-14"
    },
    "countries": null,
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 18144,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct00202878-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:improve-it-arm-1",
        "label": "ezetimibe/simvastatin",
        "intervention": null,
        "description": "One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day."
      },
      {
        "id": "cardio:improve-it-arm-2",
        "label": "simvastatin",
        "intervention": null,
        "description": "One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day."
      }
    ],
    "findings": []
  },
  "content_digest": "c1d13da6f261929daaecbcddf23e8bc8ff343f9c9c90de1ed55ce6d57f441804",
  "review": {
    "content_digest": "c1d13da6f261929daaecbcddf23e8bc8ff343f9c9c90de1ed55ce6d57f441804",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests ezetimibe added to simvastatin",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:ezetimibe",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct00202878-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Lists myocardial infarction as a condition",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:myocardial-infarction",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct00202878-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[1]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/improve-it/",
  "context_path": "api/v1/context/cardio--improve-it.md"
}