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RECRUITINGPhase 3INTERVENTIONAL

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

A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is researching an experimental drug called REGN7508 versus Acetylsalicylic Acid (ASA) (each called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery. The aim of the study is to see how effective the study drug is at preventing Venous Thromboembolism (VTE) and other related diseases after total knee replacement surgery compared to acetylsalicylic acid. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Who May Be Eligible (Plain English)

Key Who May Qualify: 1. Is undergoing a primary elective unilateral TKA 2. Is in good health based on laboratory safety testing as described in the protocol Key Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

REGN7508

Administered per the protocol

DRUG

Acetylsalicylic Acid (ASA)

Administered per the protocol

DRUG

Placebo

Administered per the protocol

Locations (10)

Sky Ridge Medical Center
Lone Tree, Colorado, United States
Medical Research of Westchester - MPLUS Research Network
Miami, Florida, United States
Phoenix Clinical Research
Tamarac, Florida, United States
NextStage Clinical Research, St. Francis Medical Park
Wichita, Kansas, United States
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
Ohio Clinical Trials
Columbus, Ohio, United States
HD Research - Memorial Hermann Village
Houston, Texas, United States
Endeavor Clinical Trials
San Antonio, Texas, United States
Spokane Joint Replacement Center
Spokane, Washington, United States