Lessons from the PACIFIC-STROKE Phase 2 Trial

In this third installment of the NeurologyLive® Special Report, Mike Sharma, MD, reviews the PACIFIC-STROKE phase 2 trial (NCT04304508), the first study to evaluate a factor XIa inhibitor in stroke patients. He explains how the study helped establish optimal dosing, assess safety, and explore which patient populations might derive the greatest benefit. Though the composite MRI endpoint was neutral, important findings emerged—including a reduction in symptomatic recurrent stroke with asundexian 50 mg, particularly among patients with atherosclerosis.

Sharma reflects on how these findings shaped the OCEANIC-STROKE program, guiding both the choice of the 50-mg dose and the inclusion of patients with vascular disease. Equally important, the favorable safety data—no meaningful rise in serious bleeding—reinforced confidence in advancing to phase 3. For clinicians, these results underscore how translational, data-driven trial design can refine antithrombotic development and accelerate progress toward safer secondary prevention strategies.