Factor XIa inhibitor for secondary prevention in patients with ischemic stroke or TIA

AXIOMATIC-SSP: Antithrombotic treatment with factor XIa inhibition to Optimize Management of Acute Thromboembolic events for Secondary Stroke Prevention

News - Sep. 6, 2022

Presented at the ESC congress 2022 by: Mukul Sharma, MD-Hamilton, Canada

Introduction and methods

In the AXIOMATIC-SSP trial -a phase 2 trial- patients with ischemic stroke or transient ischemic attack (TIA) were enrolled. In addition, patients had to have atherosclerosis in a feeding vessel to the affected area of the brain. Patients with lacunar stroke at onset were excluded, thereby eliminating patients with small vessel disease. 2295 Patients were randomized within 48 hours after symptom onset. For the first 21 days, all patients received 75 mg clopidogrel and 100 mg aspirin and thereafter, all participants received 100 mg aspirin.

Five doses of milvexian were examined- from 25 mg QD to 200 mg BID- and effects were compared to placebo treatment. At baseline and at day 90, MRIs were performed.

The combined primary endpoint was covert brain infarcts or symptomatic ischemic stroke.

Main results

  • There was no dose-response with milvexian for the primary composite endpoint of symptomatic ischemic stroke or covert brain infarction.
  • Incidence rate of symptomatic ischemic stroke were 5.5%, 4.6%. 3.8%. 4.0%, 3.5% and 7.7% with placebo, 25 mg QD, 25 mg BID, 50 mg BID, 100 mg BID and 200 mg BID, respectively.
  • There was no increase in type 3c BARC bleeding (intracranial hemorrhage including symptomatic HT) with milvexian and there was no fatal bleedings in this trial.


There was no dose-response relationship between milvexian and the composite outcome of ischemic stroke or covert brain infarct in patients with previous stroke who received 21 days of DAPT followed by single antiplatelet therapy. Milvexian did not increase symptomatic intracranial hemorrhage.

Mukul Sharma said that milvexian will be further studied in phase 3 trials.

  • Our reporting is based on the information provided at the ESC Congress -

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