ROXI-ASPEN

Summary

Patients undergoing knee replacement surgery are at increased risk for blood clots such as deep vein thrombosis and pulmonary embolism. This study assesses whether REGN7508 is effective in preventing these complications while maintaining an acceptable safety profile, including bleeding risk. The study results may help determine whether this Factor XI antibody is a safe and effective alternative to aspirin for postoperative thromboprophylaxis. 

To be included in ROXI-ASPEN, participants must be / have

• Male or female ≥ 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age at the time of signing the informed consent
• Undergoing a primary elective unilateral TKA
• In good health based on laboratory safety testing

To be included in ROXI-ASPEN, participants must not be / have

• Any condition that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant by study participation
• History of bleeding in the 6 months prior to randomization requiring hospitalization or transfusion; history of intracranial or intraocular bleeding, excessive operative or post-operative bleeding, and traumatic spinal or epidural anesthesia; history of bleeding diathesis (e.g., hemophilia A or B, von Willebrand’s Factor deficiency)
• History of thromboembolic disease or thrombophilia
• History of platelet dysfunction
• History of major surgery, including brain, spinal, or ocular, within approximately the past 6 months prior to randomization
• History of major trauma within approximately the past 6 months prior to randomization
• History of hypersensitivity or contraindication (per local label) to any of the study interventions or their excipients
• Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery
   

Keywords
Total knee arthroplasty; Deep vein thrombosis (DVT); Thromboembolism; Factor XI; Antibody; Acetylsalicylic acid