Optimal Timing of Anticoagulation After Acute Ischaemic Stroke With Atrial Fibrillation (OPTIMAS): A Multicentre, Blinded-Endpoint, Phase 4, Randomised Controlled Trial
Published on: November 22, 2024
Guideline-based practice recommends deferring direct oral anticoagulant (DOAC) initiation for 7-14 days after ischemic stroke associated with atrial fibrillation, but new evidence indicates that starting DOACs within the first 4 days is just as safe and efficient. The Phase IV study out of the United Kingdom randomized patients to either early or delayed administration of DOACs, with 1,814 and 1,807 participants, respectively, included in the modified intention-to-treat analysis. The primary outcome — a composite of recurrent ischemic stroke, symptomatic intracranial hemorrhage, unclassifiable stroke, or systemic embolism incidence at 90 days — affected 3.3% of patients in each treatment cohort. "Our findings provide reassurance that early DOAC initiation is non-inferior to delayed DOAC initiation..." the OPTIMAS authors wrote. "We identified no evidence for heterogeneity of the effect of anticoagulation timing in participants with moderate-to-severe stroke, patients who received acute reperfusion treatments (i.e., intravenous thrombolysis, mechanical thrombectomy, or both), or those who were already taking an anticoagulant, providing reassurance that early DOAC initiation does not carry a high risk of symptomatic intracranial haemorrhage in these patient groups."