{
  "release_id": "f6f6f1b6f50379ed",
  "id": "cardio:re-ly",
  "owner": "cardio",
  "kind": "study",
  "slug": "re-ly",
  "name": "RE-LY",
  "aliases": [
    "Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial that compared two doses of the blood thinner dabigatran with warfarin in people with atrial fibrillation at risk of stroke. The higher dose (150 mg twice daily) gave fewer strokes or clots elsewhere in the body than warfarin with a similar rate of major bleeding. The lower dose (110 mg twice daily) gave a similar stroke rate with less major bleeding.",
  "summary_technical": "ClinicalTrials.gov NCT00262600, a phase 3, randomized, parallel-group study sponsored by Boehringer Ingelheim with the Population Health Research Institute and Uppsala University as collaborators. The main report is Connolly et al. 2009;361(12):1139-51 (abstract read only; the journal is on the cited PubMed record). PubMed links an erratum (2010 Nov 4;363(19):1877) that was not read. The registry lists a primary completion date and no completion date. 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": "NCT00262600",
      "normalized_value": "NCT00262600",
      "match": "exact",
      "version": null,
      "label": null,
      "from_source": false
    }
  ],
  "navigation": {
    "cardio": {
      "system": [
        "heart"
      ],
      "condition-area": [
        "arrhythmias",
        "stroke"
      ]
    }
  },
  "payload": {
    "design": "Randomized, parallel-group noninferiority trial with two blinded doses of dabigatran and an open-label warfarin arm (abstract; the registry gives allocation randomized, parallel model and primary purpose prevention).",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2005-12",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2009-04",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
    },
    "completion_date": null,
    "results_first_posted": {
      "date": "2011-02-10",
      "type": null,
      "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "AR",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "AU",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "AT",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "BE",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "BR",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "BG",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "CN",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "CO",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "CZ",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "DK",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "FI",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "FR",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "DE",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "GR",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "HU",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "IN",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "IL",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "JP",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "MY",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "MX",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "NL",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "NO",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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        "code": "PE",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "PH",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "PL",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "PT",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "RO",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "RU",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "SG",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "SK",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "ZA",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "KR",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
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        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
        "code": "SE",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "CH",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "TW",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "TH",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "UA",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "code": "HK",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
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      {
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        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 18113,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct00262600-2026-10-14"
      },
      {
        "count": 18113,
        "basis": "randomized",
        "unit": "patients",
        "snapshot": "cardio:pubmed-19717844-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:re-ly-arm-dabigatran-110",
        "label": "Dabigatran 110 mg twice daily",
        "intervention": "cardio:dabigatran",
        "description": "A blinded fixed dose of 110 mg twice daily (abstract). The registry labels its two dabigatran arms dose 1 and dose 2 without milligram values."
      },
      {
        "id": "cardio:re-ly-arm-dabigatran-150",
        "label": "Dabigatran 150 mg twice daily",
        "intervention": "cardio:dabigatran",
        "description": "A blinded fixed dose of 150 mg twice daily (abstract)."
      },
      {
        "id": "cardio:re-ly-arm-warfarin",
        "label": "Warfarin",
        "intervention": null,
        "description": "Adjusted-dose warfarin given in an unblinded fashion (abstract). No separate entity is recorded for warfarin."
      }
    ],
    "findings": []
  },
  "content_digest": "4120292cd7308a4ca0cac2fc2bc66a2f25a33f424c8be11b1416902365deec61",
  "review": {
    "content_digest": "4120292cd7308a4ca0cac2fc2bc66a2f25a33f424c8be11b1416902365deec61",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests two doses of dabigatran against warfarin",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:dabigatran",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct00262600-2026-10-14",
          "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": {
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          "locator": "protocolSection.conditionsModule.conditions[0]"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
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      },
      {
        "predicate": "sponsored_by",
        "label": "Lead sponsor on the registry record",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:boehringer-ingelheim",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct00262600-2026-10-14",
          "locator": "protocolSection.sponsorCollaboratorsModule.leadSponsor.name"
        },
        "primary": false,
        "role": "lead",
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/re-ly/",
  "context_path": "api/v1/context/cardio--re-ly.md"
}