Oral Factor XIa Inhibitor Milvexian Fails to Demonstrate Impressive Results for Preventing Stroke
People with factor XI deficiency have lower rates of ischemic stroke and infrequent spontaneous bleeding, presenting an essential role in thrombosis than in hemostasis. Milvexian, an oral small-molecule inhibitor of activated factor XI, may reduce the risk of non-cardioembolic ischemic stroke without increasing bleeding risk when added to standard antiplatelet therapy.
A recent study published in the Lancet Neurology concluded that Milvexian did not significantly reduce the composite outcome of ischaemic stroke or covert brain infarction when added to dual antiplatelet therapy and did not increase the risk of significant bleeding.
This study aimed to estimate the dose-response of milvexian for recurrent ischemic cerebral events and major bleeding in those with recent ischemic stroke or TIA (transient ischemic attack).
AXIOMATIC-SSP was a phase 2 dose-finding trial conducted at 367 hospitals across 27 countries. Eligible participants aged 40 or older with acute ischemic stroke or high-risk TIA were randomly assigned to receive one of five doses of milvexian or placebo twice daily for 90 days. All participants received clopidogrel and aspirin daily for the first 90 days. The primary endpoint was the composite of ischemic stroke or covert brain infarct at 90 days, assessed with MRI and analyzed with MCP-MOD. The main safety outcome was major bleeding at 90 days, evaluated in all participants who received the study drug.
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.