Temple University Hospital (TUH) will participate in the Librexia STROKE study, a Phase 3, multi-center, randomized, double-blind, interventional clinical trial to learn if Milvexian is safe and reduces the risk of ischemic stroke compared with placebo. Milvexian is an investigational anticoagulant medication called a Factor XIa inhibitor and will be added to standard-of-care treatment for the study.
According to the U.S. Centers for Disease Control and Prevention (CDC), more than 795,000 people in the U.S. have a stroke every year; in fact, the condition affects someone every 40 seconds. Nearly 87 percent of those strokes are ischemic strokes, which occur when blood flow is blocked to the brain. Once someone experiences an ischemic stroke, they are then more likely to experience a second stroke, especially within the first year.
The Librexia study will enroll approximately 15,000 participants age 40 or older who have experienced an acute ischemic stroke or high-risk TIA (transient ischemic attack, also known as a “mini stroke” or “warning stroke”). Those who are eligible will be randomized to receive either Milvexian or placebo twice a day orally within 48 hours of their stroke or TIA, in addition to standard-of-care treatment. The current standard-of-care treatment is single or dual antiplatelet therapy, which is medication intended to prevent blood clots from forming in the body. Aspirin is one such example. Despite this standard-of-care treatment, the risk for a follow-up ischemic stroke remains high, and continued use of antiplatelet therapy or a higher dosage come with their own drawback – an increased chance of bleeding.
“Given that stroke is the No. 5 cause of death in the U.S. and disproportionately affects people of color, we are pleased that Temple University Hospital will be one of the sites participating in the Librexia STROKE study on Milvexian to look beyond the traditional standard-of-care treatment,” said Nina Gentile, MD, Professor and Vice Chair for Research in the Department of Emergency Medicine at the Lewis Katz School of Medicine at Temple University and Principal Investigator for the trial at TUH.