Coronary disease & ACSRandomised controlled trial
Milvexian with Antiplatelet Therapy after Acute Coronary Syndrome Event
- Randomised controlled trial
- phase 3
- placebo-controlled
- planned interim analysis
- terminated for futility
Authors' conclusion
Among patients with a recent acute coronary syndrome event, milvexian did not decrease the risk of cardiovascular death, myocardial infarction, or ischemic stroke but did not increase the risk of intracranial or fatal bleeding, as compared with placebo.
Study context
- Population
- Patients within 7 days after an ACS event, on standard antiplatelet therapy
- Participants
- 14,194 patients
- Comparison
- Milvexian vs placebo added to standard antiplatelet therapy
- Milvexiann = 7,094
- Placebon = 7,100reference
- Primary endpoint
- Composite of:
- CV death
- MI
- Ischemic stroke (time-to-event)
Primary result
CV death, MI or ischemic stroke · median follow-up 12.2 months
Hazard ratio
1.05
95% CI 0.91–1.21
P = 0.50
Events by treatment group
Milvexian vs Placebo
HR 1.05 (95% CI 0.91–1.21); P = 0.50
As reported in the abstract
Safety
BARC type 3c or 5 bleeding (intracranial, vision-compromising intraocular or fatal) · median follow-up 12.2 months · principal safety outcome
P = 0.88
Original publication
Milvexian with Antiplatelet Therapy after Acute Coronary Syndrome Event. N Engl J Med. Published 29 August 2026. doi:10.1056/nejmoa2608717
Summarised from the published abstract; every number is checked against it