OPTIMAS: OPtimal TIMing of Anticoagulation After Acute Ischaemic Stroke : a Randomised Controlled Trial

Summary

OPTIMAS is a large, prospective, partially blinded randomised controlled trial of early (within ≤4 days \[96hrs\]) or standard (between day 7 and day 14 after stroke onset) initiation of anticoagulation after stroke in patients with atrial fibrillation (AF), using any licensed dose of a direct oral anticoagulant (DOAC). The trial will use a non-inferiority gatekeeper approach to test for non-inferiority of early anticoagulation followed by a test for superiority, if non-inferiority is established.

Timeline

Start

2019-06-18

Primary completion

2024-05-30

Completion

2024-10-31

Outcome

Met primary endpoint

paper The upper limit of the 95% CI for the adjusted RD was less than the non-inferiority margin of 2 percentage points (pnon-inferiority=0·0003). PMID 39491870 ↗

Publications

• Lyon J, Nash PS, Ahmed N, Aram L, Balogun M, Bennett K, Best JG, Bordea E, Caverly E, Chau M, Cohen H, Cullen M, Dehbi HM, Dore CJ, Engelter ST, Fenner R, Ford GA, Gill A, Hunter R, James M, Jayanthi A, Massingham S, Murray ML, Mazurczak I, Ndoutoumou A, Norrving BG, Philip J, Sims H, Sprigg N, Vanniyasingam T, Freemantle N, Lip GYH, Werring DJ; OPTIMAS Investigators. Early Versus Delayed Anticoagulation in Acute Ischemic Stroke According to Atrial Fibrillation Subtype and Time of Diagnosis: Subgroup Analysis of the OPTIMAS Randomized Controlled Trial. Stroke. 2026 Jun;57(6):1513-1525. doi: 10.1161/STROKEAHA.125.055037. Epub 2026 Apr 1.
• Nash PS, Dehbi HM, Ahmed N, Arram L, Best JG, Balogun M, Bennett K, Bordea E, Caverly E, Chau M, Cohen H, Cullen M, Dore CJ, Engelter ST, Fenner R, Ford GA, Gill A, Hunter R, James M, Jayanthi A, Lip GYH, Massingham S, Murray ML, Mazurczak I, Ndoutoumou A, Norrving B, Philip J, Sims H, Sprigg N, Vanniyasingam T, Freemantle N, Wheeler DC, Werring DJ; OPTIMAS Investigators. Anticoagulation Timing in Acute Stroke With Atrial Fibrillation According to Chronic Kidney Disease: The OPTIMAS Trial. Stroke. 2025 Aug;56(8):1970-1979. doi: 10.1161/STROKEAHA.125.051457. Epub 2025 May 22.
• Ahmed N, Dehbi HM, Freemantle N, Best J, Nash PS, Ruffle JK, Doig D, Werring DJ. Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): statistical analysis plan for a randomised controlled trial. Trials. 2025 Feb 19;26(1):58. doi: 10.1186/s13063-025-08761-6.
• Werring DJ, Dehbi HM, Ahmed N, Arram L, Best JG, Balogun M, Bennett K, Bordea E, Caverly E, Chau M, Cohen H, Cullen M, Dore CJ, Engelter ST, Fenner R, Ford GA, Gill A, Hunter R, James M, Jayanthi A, Lip GYH, Massingham S, Murray ML, Mazurczak I, Nash PS, Ndoutoumou A, Norrving B, Sims H, Sprigg N, Vanniyasingam T, Freemantle N; OPTIMAS investigators. Optimal timing of anticoagulation after acute ischaemic stroke with atrial fibrillation (OPTIMAS): a multicentre, blinded-endpoint, phase 4, randomised controlled trial. Lancet. 2024 Oct 23:S0140-6736(24)02197-4. doi: 10.1016/S0140-6736(24)02197-4. Online ahead of print.
• Best JG, Arram L, Ahmed N, Balogun M, Bennett K, Bordea E, Campos MG, Caverly E, Chau M, Cohen H, Dehbi HM, Dore CJ, Engelter ST, Fenner R, Freemantle N, Hunter R, James M, Lip GY, Murray ML, Norrving B, Sprigg N, Veltkamp R, Zaczyk I, Werring DJ; OPTIMAS investigators. Optimal timing of anticoagulation after acute ischemic stroke with atrial fibrillation (OPTIMAS): Protocol for a randomized controlled trial. Int J Stroke. 2022 Jun;17(5):583-589. doi: 10.1177/17474930211057722. Epub 2022 Jan 12.

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Indications