REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Purpose
This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called Acetylsalicylic Acid (ASA). 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)
Condition
- Symptomatic Venous Thromboembolism (VTE)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Is undergoing a primary elective unilateral TKA 2. Is in good health based on laboratory safety testing as described in the protocol
Exclusion Criteria
- 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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental REGN7508 and Placebo |
|
|
|
Active Comparator Placebo and ASA |
|
Recruiting Locations
Horizon Clinical Research
La Mesa, California 91942
La Mesa, California 91942
Eisenhower Medical Center
Rancho Mirage, California 92270
Rancho Mirage, California 92270
Sky Ridge Medical Center
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
South Florida Joint Replacement Center
Deerfield Beach, Florida 33064
Deerfield Beach, Florida 33064
Medical Research of Westchester - MPLUS Research Network
Miami, Florida 33165
Miami, Florida 33165
Phoenix Clinical Research
Tamarac, Florida 33321
Tamarac, Florida 33321
Endeavor Health
Skokie, Illinois 60076
Skokie, Illinois 60076
The Orthopaedic Research Foundation, Inc.
Indianapolis, Indiana 46278
Indianapolis, Indiana 46278
NextStage Clinical Research, St. Francis Medical Park
Wichita, Kansas 67214
Wichita, Kansas 67214
Velocity Clinical Research, Annapolis
Annapolis, Maryland 21401
Annapolis, Maryland 21401
Sinai Hospital of Baltimore, Inc.
Baltimore, Maryland 21215
Baltimore, Maryland 21215
Holy Name Medical Center
Teaneck, New Jersey 07666
Teaneck, New Jersey 07666
University of Rochester Medical Center
Rochester, New York 14623-5863
Rochester, New York 14623-5863
Eximia Equihealth Research-Raleigh. LLC
Raleigh, North Carolina 27612
Raleigh, North Carolina 27612
The Vein and Vascular Center at Raleigh Radiology
Raleigh, North Carolina 27612
Raleigh, North Carolina 27612
Coastal Vascular Institute, PA
Wilmington, North Carolina 28401
Wilmington, North Carolina 28401
University of Cincinnati
Cincinnati, Ohio 45267
Cincinnati, Ohio 45267
The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Columbus, Ohio 43210
Ohio Clinical Trials
Columbus, Ohio 43212
Columbus, Ohio 43212
University of Pittsburgh
Pittsburgh, Pennsylvania 15213-3108
Pittsburgh, Pennsylvania 15213-3108
HD Research - Memorial Hermann Village
Houston, Texas 77043
Houston, Texas 77043
NextStage Clinical Research, All American Orthopedics and Sports Medicine
Houston, Texas 77058
Houston, Texas 77058
Carilion Clinic
Roanoke, Virginia 24015
Roanoke, Virginia 24015
Spokane Joint Replacement Center
Spokane, Washington 99218
Spokane, Washington 99218
More Details
- Status
- Recruiting
- Sponsor
- Regeneron Pharmaceuticals