Arrhythmias & electrophysiologyRandomised controlled trial
Apixaban to Prevent Recurrence After Cryptogenic Stroke in Patients With Atrial Cardiopathy
- Randomised controlled trial
- multicentre
- double-blind
- phase 3
- stopped for futility after planned interim analysis
185 sites, NIH StrokeNet and Canadian Stroke Consortium, February 1, 2018, through February 28, 2023
Authors' conclusion
In patients with cryptogenic stroke and evidence of atrial cardiopathy without atrial fibrillation, apixaban did not significantly reduce recurrent stroke risk compared with aspirin.
Study context
- Population
- Patients with cryptogenic stroke and evidence of atrial cardiopathy, without AF at randomisationof target 1100
- Participants
- 1,015 patients
- Comparison
- Apixaban vs aspirin
- Apixabann = 507
- Aspirinn = 508reference
- Primary endpoint
- Recurrent stroke (time-to-event)
- Follow-up
- Mean 1.8 years
Primary result
Recurrent stroke
Hazard ratio
1.00
95% CI 0.64–1.55
Events by treatment group
Apixaban vs Aspirin
HR 1.00 (95% CI 0.64–1.55)
As reported in the abstract
Safety
Annualized rate
| Outcome | Apixaban | Aspirin | HR (95% CI) | |
|---|---|---|---|---|
| Other major hemorrhage | 0.7% | 0.8% | 1.02 (0.29–3.52) | |
| 0.20.5125Hazard ratio (log scale) |
| Outcome | Apixaban | Aspirin | Estimate |
|---|---|---|---|
| Symptomatic intracranial hemorrhage | 0 events | annualized rate 1.1% |
Original publication
Apixaban to Prevent Recurrence After Cryptogenic Stroke in Patients With Atrial Cardiopathy. JAMA. Published 20 February 2024. doi:10.1001/jama.2023.27188
Summarised from the published abstract; every number is checked against it