Arrhythmias & electrophysiologyRandomised controlled trial
Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): a multicentre, blinded-endpoint, phase 4, randomised controlled trial
- Randomised controlled trial
- multicentre
- open-label
- blinded-endpoint
- parallel-group
- phase 4
- non-inferiority
Authors' conclusion
Early DOAC initiation within 4 days after ischaemic stroke associated with atrial fibrillation was non-inferior to delayed initiation for the composite outcome of ischaemic stroke, intracranial haemorrhage, unclassifiable stroke, or systemic embolism at 90 days.
Study context
- Population
- Adults with AF and acute ischaemic stroke, physician uncertain of optimal DOAC timing, 100 UK hospitals3,621 in modified ITT
- Participants
- 3,648 adults
- Comparison
- Early vs delayed DOAC initiation
- Earlyn = 1,814
- Delayedn = 1,807reference
- Primary endpoint
- Recurrent ischaemic stroke, symptomatic intracranial haemorrhage, unclassifiable stroke or systemic embolism
- Follow-up
- 90 days
Primary result
As reported in the abstract
Adjusted risk difference
0.000
95% CI −0.011 to 0.012
P = 0.0003 for non-inferiority
Events by treatment group
Early vs Delayed
adjusted risk difference 0.000 (95% CI −0.011 to 0.012); P for non-inferiority = 0.0003
Non-inferiority margin 2 as printed, not drawn
Safety
| Outcome | Early | Delayed | adjusted RD (CI) | P value | |
|---|---|---|---|---|---|
| Symptomatic intracranial haemorrhage | 0.6% | 0.7% | 0.001 (−0.004 to 0.006) | P = 0.78 | |
| −0.00500.0050.01Difference (linear scale) |
Original publication
Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): a multicentre, blinded-endpoint, phase 4, randomised controlled trial. Lancet. Published 23 October 2024. doi:10.1016/s0140-6736(24)02197-4
Summarised from the published abstract; every number is checked against it