Moderator of 1 Session
Session Description:
A contemporary review of the current management and unmet need in ischemic stroke. An examination of the evidence of the emerging potential target of anticoagulation – Factor XI.
Presenter of 5 Presentations
Welcome and Introductions
Panel Discussion and Q&A
Emerging Therapies and Future Plans
Factor XIa Inhibition: What Is the Rational in Context of Secondary Stroke Prevention
FACTOR XIA INHIBITOR MILVEXIAN FOR SECONDARY STROKE PREVENTION: RESULTS OF THE AXIOMATIC-SSP PHASE 2 TRIAL
Abstract
Background and Aims
The early risk of stroke remains high in those with symptomatic cerebrovascular disease despite antiplatelet therapy. Reduced FXI activity is associated with lower risk for stroke without increased bleeding. We aimed to estimate the dose-response relationship of milvexian, an oral inhibitor of FXIa, on stroke recurrence and bleeding in patients with acute ischemic stroke or high-risk TIA receiving dual antiplatelet therapy (DAPT).
Methods
In this phase 2 double-blinded, placebo-controlled trial, eligible participants with an ischemic stroke with a NIHSS ≤ 7 or a TIA with an ABCD2 score ≥ 6 or motor symptoms, were randomized within 48 hours of onset to receive one of 5 doses of milvexian or matching placebo for 90 days. All participants received a 300mg loading dose of clopidogrel followed by 75mg for 21 days, and aspirin 100mg for 90 days. MRI was obtained at baseline and 90 days. The primary efficacy endpoint was a composite of ischemic stroke or incident covert infarct on MRI. The main safety endpoint was type 3 or 5 bleeding according to the Bleeding Academic Research Consortium classification.
Results
We randomized 2366 participants from 367 sites in 27 countries. Participants had a median age of 71 years and 64% were male. Most index events (76%) were stroke. The primary end-point occurred in 343/2123 (16%). Final results for all countries will be presented.
Conclusions
AXIOMATIC-SSP is the largest dose-finding trial of an anticoagulant in stroke. The results will inform an assessment of efficacy and safety of milvexian for secondary stroke prevention.