{
  "release_id": "73130c34862e2d06",
  "id": "cardio:secure-trial",
  "owner": "cardio",
  "kind": "study",
  "slug": "secure-trial",
  "name": "SECURE",
  "aliases": [
    "Secondary Prevention of Cardiovascular Disease in the Elderly Trial"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A European trial in adults aged 65 or older who had had a heart attack in the previous 6 months and had at least one further risk condition. 2499 patients were randomized to a once-daily polypill combining three heart medicines or to usual care. Over a median of 36 months, the polypill group had fewer major cardiovascular events. Patients in the polypill group reported better adherence, and adverse events were similar between groups.",
  "summary_technical": "Trial (NCT02596126) whose registry lead sponsor is Fundacion Centro Nacional de Investigaciones Cardiovasculares Carlos III (accents removed here), registry phase 3, randomized, parallel, masking none, primary purpose prevention. Sites in seven European countries. The abstract counts 2499 randomized with group denominators of 1237 and 1229; the sources do not explain the difference. The registry holds results posted 2025-05-23, which this record does not extract. Numbers are on the claim. Only the PubMed abstract and the registry record were read.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-15",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT02596126",
      "normalized_value": "NCT02596126",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "coronary-and-vascular-disease"
      ]
    }
  },
  "payload": {
    "design": "Randomized, parallel-group, open-label (masking none in the registry) phase 3 trial of a polypill-based strategy against usual care for secondary prevention after a myocardial infarction. The registry records the primary purpose as prevention.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
      }
    ],
    "start_date": {
      "date": "2016-07",
      "type": null,
      "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
    },
    "primary_completion_date": {
      "date": "2021-10-31",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
    },
    "completion_date": {
      "date": "2022-03-31",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
    },
    "results_first_posted": {
      "date": "2025-05-23",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
    },
    "countries": [
      {
        "code": "CZ",
        "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
      },
      {
        "code": "FR",
        "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
      },
      {
        "code": "HU",
        "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
      },
      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
      },
      {
        "code": "PL",
        "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
      },
      {
        "code": "ES",
        "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
      }
    ],
    "care_setting": {
      "description": "Trial sites in seven European countries (Spain, Italy, Germany, France, Hungary, Poland and the Czech Republic), per the registry description.",
      "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
    },
    "stopped_early": null,
    "enrollment": [
      {
        "count": 2499,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct02596126-2026-10-15"
      },
      {
        "count": 2499,
        "basis": "randomized",
        "unit": "patients",
        "snapshot": "cardio:pubmed-36018037-2026-10-15"
      }
    ],
    "arms": [
      {
        "id": "cardio:secure-trial-arm-polypill",
        "label": "Cardiovascular polypill",
        "intervention": "cardio:polypill",
        "description": "A once-daily polypill with three heart medicines, taken by mouth (registry); the doses and contents are on the polypill page."
      },
      {
        "id": "cardio:secure-trial-arm-usual-care",
        "label": "Usual care",
        "intervention": null,
        "description": "Standard secondary-prevention therapy per European guidelines, with drugs and doses at the discretion of the treating physicians (registry)."
      }
    ],
    "findings": []
  },
  "content_digest": "7b84e3e97d94c50da49a4ea7fd8f32c0a73ee216f214936cb86cc5feeb8c2648",
  "review": {
    "content_digest": "7b84e3e97d94c50da49a4ea7fd8f32c0a73ee216f214936cb86cc5feeb8c2648",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests this care strategy",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:polypill",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct02596126-2026-10-15",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Studies people with this 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-nct02596126-2026-10-15",
          "locator": "protocolSection.conditionsModule.conditions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/secure-trial/",
  "context_path": "api/v1/context/cardio--secure-trial.md"
}