REGN7508 versus aspirin to prevent blood clots after single-knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial compares REGN7508, acetylsalicylic acid (aspirin), and placebo for prevention of venous thromboembolism after elective unilateral total knee arthroplasty in adults. Participants judged medically fit will receive one of the study drugs and be followed for VTE events, safety, drug blood levels, and formation of anti-drug antibodies. Key exclusions include recent major bleeding, prior thromboembolic disease or thrombophilia, platelet dysfunction, and receipt of preoperative enoxaparin. The trial is sponsored by Regeneron Pharmaceuticals and is being conducted at several U.S. clinical sites.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. Is undergoing a primary elective unilateral TKA
2. Is in good health based on laboratory safety testing as described in the protocol

Key Exclusion Criteria:

1. 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
2. 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 (eg, hemophilia A or B, von Willebrand's Factor deficiency)
3. History of thromboembolic disease or thrombophilia
4. History of platelet dysfunction
5. Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Where it's running

• Horizon Clinical Research
  La Mesa, California, United States Recruiting
• Eisenhower Medical Center
  Rancho Mirage, California, United States Recruiting
• CARI Clinical Trials
  Riverside, California, United States Recruiting
• HCA HealthONE Centennial
  Englewood, Colorado, United States Recruiting
• HCA HealthONE, HCA HealthONE Sky Ridge
  Lone Tree, Colorado, United States Recruiting
• South Florida Joint Replacement Center
  Deerfield Beach, Florida, United States Recruiting

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.