{
  "release_id": "5dcd9b263fe17744",
  "id": "cardio:odyssey-outcomes",
  "owner": "cardio",
  "kind": "study",
  "slug": "odyssey-outcomes",
  "name": "ODYSSEY OUTCOMES (alirocumab after acute coronary syndrome)",
  "aliases": [
    "ODYSSEY OUTCOMES",
    "ODYSSEY Outcomes"
  ],
  "atlases": [
    "cardio"
  ],
  "summary_plain": "A large trial of 18,924 people who had had an acute coronary syndrome 1 to 12 months earlier and were taking a strong statin. Half also received alirocumab, an injected PCSK9 antibody, and half received placebo. Alirocumab lowered the rate of further heart and blood-vessel events over a median of 2.8 years.",
  "summary_technical": "Phase 3, randomized, double-blind, placebo-controlled trial (NCT01663402), 18,924 participants enrolled, started 2012-10 and primary completion 2018-01-23. The abstract reports the primary composite in 9.5% against 11.1% (hazard ratio 0.85, 95% CI 0.78 to 0.93). Funded by Sanofi and Regeneron according to the paper; Sanofi is the registry lead sponsor and Regeneron a collaborator. The registry names atherosclerotic cardiovascular disease as the condition.",
  "editorial_state": "draft",
  "last_substantive_edit": "2026-10-14",
  "last_evidence_check": "2026-10-14",
  "next_review_due": null,
  "identifiers": [
    {
      "scheme": "nct",
      "value": "NCT01663402",
      "normalized_value": "NCT01663402",
      "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: double. Primary purpose: prevention. (Registry values, in lower case.)",
    "drug_phase": "3",
    "registry_statuses": [
      {
        "status": "COMPLETED",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      }
    ],
    "start_date": {
      "date": "2012-10",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
    },
    "primary_completion_date": {
      "date": "2018-01-23",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
    },
    "completion_date": {
      "date": "2018-01-23",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
    },
    "results_first_posted": {
      "date": "2019-03-18",
      "type": "actual",
      "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
    },
    "countries": [
      {
        "code": "US",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "AR",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "AU",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "AT",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "BE",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "BR",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "BG",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "CA",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "CL",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "CN",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "CO",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "HR",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "CZ",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "DK",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
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        "code": "EE",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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        "code": "FI",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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        "code": "GR",
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      {
        "code": "HU",
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      },
      {
        "code": "IN",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "IL",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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      {
        "code": "IT",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "JP",
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        "code": "LV",
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        "code": "LT",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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      },
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        "code": "NL",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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      {
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        "code": "LK",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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      {
        "code": "CH",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "TW",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "TH",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "UA",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "GB",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "BA",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      },
      {
        "code": "HK",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
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      {
        "code": "TR",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      }
    ],
    "care_setting": null,
    "stopped_early": null,
    "enrollment": [
      {
        "count": 18924,
        "basis": "enrolled",
        "unit": "participants",
        "snapshot": "cardio:ctgov-nct01663402-2026-10-14"
      }
    ],
    "arms": [
      {
        "id": "cardio:odyssey-outcomes-arm-1",
        "label": "Placebo",
        "intervention": null,
        "description": "Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for up to 64 months."
      },
      {
        "id": "cardio:odyssey-outcomes-arm-2",
        "label": "Alirocumab 75 mg Q2W/Up to 150 mg Q2W",
        "intervention": null,
        "description": "Alirocumab 75 mg SC injection Q2W added to stable LMT for up to 64 months. Alirocumab dose up-titrated to 150 mg Q2W from Month 2 when Low-Density Lipoprotein Cholesterol (LDL-C) levels \\>=50 mg/dL (1.29 mmol/L) at Month 1; or if up-titration was missed due to unavailability of LDL-C value, it was up-titrated at month 4 based on LDL-C value at Month 2. For participants receiving 150 mg Q2W, alirocumab dose was down-titrated in a blinded manner to 75 mg Q2W if two consecutive values of LDL-C were \\<25 mg/dL (0.65 mmol/L). For participants receiving 75 mg Q2W, alirocumab dose was switched to placebo in a blinded manner if two consecutive values of LDL-C were \\<15 mg/dL (0.39 mmol/L)."
      }
    ],
    "findings": []
  },
  "content_digest": "5a592a09ebc5299c46fee46cbc3606f753154e6f1f2cce2cc706e09c5cb116ba",
  "review": {
    "content_digest": "5a592a09ebc5299c46fee46cbc3606f753154e6f1f2cce2cc706e09c5cb116ba",
    "current": [],
    "conflicting": [],
    "stale": [],
    "inactive": []
  },
  "claims": [],
  "decisions": [],
  "milestones": [],
  "relationships": {
    "outgoing": [
      {
        "predicate": "investigates",
        "label": "Tests alirocumab",
        "clinical_claim_not_fact": false,
        "family": "sourced",
        "other_entity_id": "cardio:alirocumab",
        "other_entity_in_atlas": true,
        "claim_id": null,
        "evidence": {
          "snapshot_id": "cardio:ctgov-nct01663402-2026-10-14",
          "locator": "protocolSection.armsInterventionsModule.interventions[0].name"
        },
        "primary": false,
        "role": null,
        "valid_from": null,
        "valid_to": null
      }
    ],
    "incoming": []
  },
  "page_path": "studies/odyssey-outcomes/",
  "context_path": "api/v1/context/cardio--odyssey-outcomes.md"
}