Randomised controlled trial
Early versus Later Anticoagulation for Stroke with Atrial Fibrillation
- Randomised controlled trial
- investigator-initiated
- open-label
- blinded outcome assessment
- 103 sites in 15 countries
Authors' conclusion
In this trial, the incidence of recurrent ischemic stroke, systemic embolism, major extracranial bleeding, symptomatic intracranial hemorrhage, or vascular death at 30 days was estimated to range from 2.8 percentage points lower to 0.5 percentage points higher (based on the 95% confidence interval) with early than with later use of DOACs.
Study context
- Population
- Persons with AF who have had an acute ischemic stroke (37% minor, 40% moderate, 23% major stroke)
- Participants
- 2,013 persons
- Comparison
- Early vs later DOAC initiation after acute ischemic stroke
- Earlyn = 1,006
- Latern = 1,007reference
- Primary endpoint
- Composite of:
- Recurrent ischemic stroke
- Systemic embolism
- Major extracranial bleeding
- Symptomatic intracranial hemorrhage
- Vascular death
- Follow-up
- 30 days after randomization
Primary result
As reported in the abstract
30 days
Risk difference
−1.18 percentage points
95% CI −2.84 to 0.47
Events by treatment group
Early vs Later
risk difference −1.18 percentage points (95% CI −2.84 to 0.47)
Secondary outcomes
| Outcome | Early | Later | OR (95% CI) | |
|---|---|---|---|---|
| Recurrent ischemic stroke · 30 days | 1.4% | 2.5% | 0.57 (0.29–1.07) | |
| Recurrent ischemic stroke · 90 days | 1.9% | 3.1% | 0.60 (0.33–1.06) | |
| 0.20.5125Odds ratio (log scale) |
Safety
Symptomatic intracranial hemorrhage · 30 days
Original publication
Early versus Later Anticoagulation for Stroke with Atrial Fibrillation. N Engl J Med. Published 24 May 2023. doi:10.1056/nejmoa2303048
Summarised from the published abstract; every number is checked against it