{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:aristotle",
  "owner": "cardio",
  "kind": "study",
  "slug": "aristotle",
  "name": "ARISTOTLE",
  "aliases": [
    "Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial that compared the blood thinner apixaban with warfarin in people with atrial fibrillation who had at least one other risk factor for stroke. The authors conclude that apixaban was superior to warfarin in preventing stroke or a clot elsewhere in the body, caused less bleeding, and was linked with lower death from any cause.",
  "summary_technical": "ClinicalTrials.gov NCT00412984, a phase 3, randomized, double-blind, parallel-group, warfarin-controlled study sponsored by Bristol-Myers Squibb (industry), completed 2011-05-25. The main report is Granger et al. 2011;365(11):981-92 (abstract read only; the journal is on the cited PubMed record). Enrollment differs by source: the registry gives 20976 and the abstract says 18,201 patients; the difference is not explained and not reconciled. The registry marks the results-first-posted date ESTIMATED, so no date type is recorded for it. No structured findings are recorded here; the numbers are on the claim.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-15",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT00412984",
      "normalized_value": "NCT00412984",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "arrhythmias",
        "stroke"
      ]
    }
  },
  "payload": {
    "design": "Randomized, double-blind, parallel-group, active-controlled (warfarin) phase 3 trial. The registry gives allocation randomized, parallel model, double masking and primary purpose prevention. The abstract says the trial was designed to test noninferiority, with key secondary objectives of testing superiority for the primary outcome and for the rates of major bleeding and death from any cause.",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2006-12-31",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2011-05-25",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
    },
    "completion_date": {
      "date": "2011-05-25",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
    },
    "results_first_posted": {
      "date": "2013-04-29",
      "type": null,
      "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "AR",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "AU",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "AT",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "BE",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "BR",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "CL",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "CN",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "CO",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "CZ",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "DK",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "FI",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "FR",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "HU",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "IN",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "IL",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "JP",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "MY",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "MX",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "NL",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "NO",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "PE",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "PH",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "PL",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "PR",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "RO",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "RU",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "SG",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "ZA",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "KR",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "ES",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "SE",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "CH",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "TW",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "UA",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "HK",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "code": "TR",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 20976,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct00412984-2026-10-14"
      },
      {
        "count": 18201,
        "basis": "unknown",
        "unit": "patients",
        "snapshot": "cardio:pubmed-21870978-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:aristotle-arm-apixaban",
        "label": "Apixaban",
        "intervention": "cardio:apixaban",
        "description": "Apixaban at 5 mg twice daily (abstract). The registry lists oral tablets of 5.0 mg or 2.5 mg twice daily."
      },
      {
        "id": "cardio:aristotle-arm-warfarin",
        "label": "Warfarin",
        "intervention": null,
        "description": "Warfarin adjusted to a target international normalized ratio of 2.0 to 3.0 (abstract). No separate entity is recorded for warfarin."
      }
    ],
    "findings": []
  },
  "content_digest": "7a727398e135236b9fbaa75c4786950524538d4be126353dc1b4bbad5befe04f",
  "review": {
    "content_digest": "7a727398e135236b9fbaa75c4786950524538d4be126353dc1b4bbad5befe04f",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests apixaban against warfarin",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:apixaban",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct00412984-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[1].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      },
      {
        "predicate": "investigates",
        "label": "Lists atrial fibrillation as its first condition",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:atrial-fibrillation",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct00412984-2026-10-14",
          "locator": "protocolSection.conditionsModule.conditions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/aristotle/",
  "context_path": "api/v1/context/cardio--aristotle.md"
}