Antithrombotic treatment with factor XIa inhibition to Optimize Management of Acute Thromboembolic events in Secondary Stroke Prevention

AXIOMATIC-SSP is a global, phase 2, double-blinded, placebo-controlled, dose-ranging trial assessing the efficacy of BMS-986177 – an oral Factor Xia inhibitor in the prevention of new ischemic stroke or new convert brain infarct. The sponsor is Bristol-Myers-Squibb and our local PI is Dr. Neil Hunter.

The study population of this trial are adults over 40 who have had a mild stroke or high-risk TIA. These participants should also be prescribed dual antiplatelet therapy as standard of care.

Eligible patients must also have presence of atherosclerotic plaque in a relevant feeding artery (usually Carotid Dopplers) and must be eligible for a study-specific MRI within 48 hours of symptom onset.  Participants are randomised to BMS-986177 25mg, 100mg or placebo.

After many months of meetings, set-up, site initiation visits, refresher training and a full-on pause due to the COVID-19 pandemic, the study finally got the green light to open for recruitment on the 19^th October 2020 and successfully recruited our first participant on the 27^th October 2020.