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A study to compare REGN7508 and acetylsalicylic acid for preventing blood clots in adults undergoing elective total knee replacement.

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What is this study about?

This study aims to evaluate the effectiveness of a new medication for preventing blood clots following a planned Total Knee Arthroplasty, which is a surgical procedure to replace a damaged knee joint with an artificial one. The condition being studied is Venous Thromboembolism, a term used to describe blood clots that form in the veins. This condition can include Deep Vein Thrombosis, which is a clot typically located in the deep veins of the leg, or a Pulmonary Embolism, which occurs when a blood clot travels to the lungs.

Participants in the study will be assigned to receive either the study drug REGN7508, which is a Factor XI monoclonal antibody delivered through an intravenous injection, or acetylsalicylic acid, also known as aspirin. Some participants may also receive a placebo. The study is designed so that neither the researchers nor the participants know which treatment is being administered during the process.

Who Can Join the Study?

  • You must be scheduled for a primary elective unilateral TKA, which means a planned, non-emergency surgery to replace one knee joint.
  • You must be in good health, as confirmed by laboratory safety testing, which are medical tests performed on your blood or other samples to ensure your body is healthy enough for the study.
  • You must meet any other specific medical requirements defined by the study rules.
  • You must be either male or female.
  • You must fall within the specific age range required for this study.

Who Cannot Join the Study?

  • You have any medical condition that the doctor believes could confuse the results of the study or increase your safety risks while participating.
  • You have a history of bleeding in the 6 months before starting the study that required you to stay in the hospital or receive a blood transfusion (a procedure where blood is put into your body).
  • You have a history of bleeding inside the brain (intracranial) or inside the eye (intraocular).
  • You have a history of heavy bleeding during or after a surgical operation.
  • You have experienced injury or bleeding related to spinal anesthesia or epidural anesthesia (numbing medicine injected into the back).
  • You have a history of a bleeding disorder, which is a condition where your blood does not clot normally, such as hemophilia or von Willebrand’s Factor deficiency.
  • You have a history of thromboembolic disease, which means blood clots that have traveled through your blood vessels, or thrombophilia, which is a condition that makes your blood more likely to clot.
  • You have a history of platelet dysfunction, meaning the tiny cells in your blood that help stop bleeding (platelets) are not working correctly.
  • You have taken or plan to take enoxaparin (a blood-thinning medicine) the day before your TKA (total knee replacement surgery).
  • You meet any other reasons for being left out of the study as defined by the specific rules of this research.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
General Hospital Of Nea Ionia Konstantopouleio Patision Nea Ionia Greece
Henry Dunant Hospital Center Athens Greece
Organization Academic Orthopaedic Department Papageorgiou G.H. Auth Thessaloniki Greece
Ospedale Galeazzi S.p.A. Milan Italy
Ooulplxa Ihojdbhdbdk Rome Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Greece Greece
Not yet recruiting
05.12.2025
Italy Italy
Not yet recruiting
05.12.2025

Trial locations

Investigated drugs:

REGN7508 is a medication given through an injection into a vein. It is being tested to see if it can help prevent the formation of dangerous blood clots in patients after they have undergone elective total knee replacement surgery.

Aspirin is a medication taken by mouth. In this study, it is being used as a comparison to see how well it prevents blood clots in patients after they have undergone elective total knee replacement surgery.

Venous thromboembolism – This condition occurs when a blood clot forms in one or more of the veins in the body. It often begins as a deep vein thrombosis, where a clot develops in a deep vein, most commonly in the legs. If the clot breaks loose, it can travel through the bloodstream to the lungs, causing a pulmonary embolism. The progression depends on the size and location of the clot within the circulatory system. This process can involve various parts of the venous network.

Trial ID:
2025-520479-25-00
Protocol code:
R7508-DVT-24120
NCT ID:
NCT07213778
Trial Phase:
Therapeutic confirmatory (Phase III)

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