Study Comparing REGN7508 and Acetylsalicylic Acid to Prevent Blood Clots After Knee Replacement Surgery in Adults

What this Trial Is About

Researchers are studying an experimental drug called REGN7508 and comparing it to Acetylsalicylic Acid ASA in adults undergoing elective, one-sided total knee replacement surgery. The study aims to evaluate how well REGN7508 prevents Venous Thromboembolism VTE and related conditions after surgery. This Phase 3 trial also investigates potential side effects, the amount of the study drug in the blood over time, and whether the body develops antibodies against the drug. Participants are randomly assigned to receive either REGN7508 with a placebo or ASA with a placebo. All treatments are given according to the study protocol. The trial is double-blinded and multicenter, ensuring neither participants nor researchers know who receives which treatment. The study period includes monitoring up to 90 days to assess safety and drug levels. During the trial, participants will be closely monitored for symptomatic VTE, death, bleeding events, and adverse effects through day 30 to day 90 visits. Blood samples will be collected to measure drug concentration and antibody development. Researchers will evaluate the time to events such as deep vein thrombosis, pulmonary embolism, and overall safety outcomes. The entire study is expected to last until July 2027.

REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants