# ODYSSEY OUTCOMES (alirocumab after acute coronary syndrome)

Study · id `cardio:odyssey-outcomes` · Cardiovascular Atlas · release `5dcd9b263fe17744` (public)

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Also called: ODYSSEY OUTCOMES; ODYSSEY Outcomes

Browse, condition area: Coronary and vascular disease  

## In plain language

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.

## Technical summary

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.

## Key facts

- Design: Allocation: randomized. Intervention model: parallel. Masking: double. Primary purpose: prevention. (Registry values, in lower case.)
- Phase: Phase 3
- Enrolled: 18924 participants (enrolled count; ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, snapshot `cardio:ctgov-nct01663402-2026-10-14`, retrieved 2026-10-14)
- Started: 2012-10 (actual) (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, snapshot `cardio:ctgov-nct01663402-2026-10-14`, retrieved 2026-10-14)
- Primary completion: 2018-01-23 (actual) (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, snapshot `cardio:ctgov-nct01663402-2026-10-14`, retrieved 2026-10-14)
- Completion: 2018-01-23 (actual) (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, snapshot `cardio:ctgov-nct01663402-2026-10-14`, retrieved 2026-10-14)
- Results first posted: 2019-03-18 (actual) (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, snapshot `cardio:ctgov-nct01663402-2026-10-14`, retrieved 2026-10-14)
- Countries: United States; Argentina; Australia; Austria; Belgium; Brazil; Bulgaria; Canada; Chile; China; Colombia; Croatia; Czechia; Denmark; Estonia; Finland; France; Georgia; Germany; Greece; Guatemala; Hungary; India; Israel; Italy; Japan; Latvia; Lithuania; Malaysia; Mexico; Netherlands; New Zealand; North Macedonia; Norway; Peru; Philippines; Poland; Portugal; Romania; Russia; Serbia; Singapore; Slovakia; Slovenia; South Africa; South Korea; Spain; Sri Lanka; Sweden; Switzerland; Taiwan; Thailand; Ukraine; United Kingdom; Bosnia & Herzegovina; Hong Kong SAR China; Türkiye (ODYSSEY Outcomes: Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome During Treatment With Alirocumab, snapshot `cardio:ctgov-nct01663402-2026-10-14`, retrieved 2026-10-14)
- Care setting: Not reported
- Registry status: "COMPLETED" (U.S. National Library of Medicine (ClinicalTrials.gov), snapshot `cardio:ctgov-nct01663402-2026-10-14`, retrieved 2026-10-14)

## Connected pages

- Tests alirocumab: Alirocumab (`cardio:alirocumab`)

## Provenance

Content hash: 5a592a09ebc5299c46fee46cbc3606f753154e6f1f2cce2cc706e09c5cb116ba
Last substantive edit: 2026-10-14
Evidence last checked: 2026-10-14