ESC 2022: Milvexian reduces ischemic stroke risk without increasing bleeding risk (AXIOMATIC-SSP study)

August 28, 2022: Milvexian should be further investigated to reduce ischemic stroke risk without increasing clinical Significant bleeding capacity

Patients with prior ischemic stroke or TIA have an approximately 5-10% risk of ischemic stroke in the first few months

AXIOMATIC-SSP is the largest dose-finding trial of anticoagulants in the stroke population

The AXIOMATIC-SSP trial was an anticoagulant-related maximum-dose outcome trial in stroke patients

A total of 2366 patients from 367 locations in 27 countries were included in the study

Patients were randomized to five doses of milvexian (25 mg, 50 mg, 100 mg, and 200 mg twice daily; 25 mg once daily) or placebo for 90 days

All patients received open-label aspirin and clopidogrel background therapy for 21 days and open-label aspirin for 22-90 days

The primary efficacy endpoint was ischemic stroke during treatment or cerebral infarction on MRI at 90 days

The study included 2,366 patients from 367 sites in 27 countries

The investigators found that although the incidence of the primary efficacy endpoint was numerically lower for the 50 mg and 100 mg twice daily doses, there was no apparent dose response (16.

In the intention-to-treat population, all doses of milvexian (except 200 mg twice daily) numerically reduced the risk of ischemic stroke (except occult stroke)

The incidence of major bleeding was low overall (placebo 0.

"Based on the observed ischemic stroke efficacy signals, bleeding profile, and overall safety and tolerability, milvexian will be further investigated in a phase 3 trial in the stroke population," said lead investigator Mukul Sharma, PhD, of McMaster University in Hamilton, Canada.

References:

FXIa inhibitor milvexian for secondary stroke prevention-Late-breaking results of the AXIOMATIC-SSP Phase 2 randomized trial.