Arrhythmias & electrophysiologyRandomised controlled trial
Asundexian versus Apixaban in Patients with Atrial Fibrillation
- Randomised controlled trial
- phase 3
- international
- double-blind
- non-inferiority
- stopped prematurely
- The trial was stopped prematurely at the recommendation of the independent data monitoring committee.
Authors' conclusion
Among patients with atrial fibrillation at risk for stroke, treatment with asundexian at a dose of 50 mg once daily was associated with a higher incidence of stroke or systemic embolism than treatment with apixaban in the period before the trial was stopped prematurely. There were fewer major bleeding events with asundexian than with apixaban during this time.
Study context
- Population
- High-risk patients with AFITT population
- Participants
- 14,810 patients
- Comparison
- Asundexian 50 mg once daily vs standard-dose apixaban
- Primary endpoint
- Stroke or systemic embolism (noninferiority of asundexian vs apixaban)
Primary result
Stroke or systemic embolism
Hazard ratio
3.79
95% CI 2.46–5.83
Events by treatment group
Asundexian vs Apixaban
HR 3.79 (95% CI 2.46–5.83)
As reported in the abstract
Safety
| Outcome | Asundexian | Apixaban | HR (95% CI) | |
|---|---|---|---|---|
| Major bleeding (primary safety objective) | 0.2% | 0.7% | 0.32 (0.18–0.55) | |
| 0.20.5125Hazard ratio (log scale) |
Any adverse event
- Incidence appeared similar in the two groups
Original publication
Asundexian versus Apixaban in Patients with Atrial Fibrillation. N Engl J Med. Published 1 September 2024. doi:10.1056/nejmoa2407105
Summarised from the published abstract; every number is checked against it