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

Phase 3RecruitingNCT07213778

Regeneron Pharmaceuticals2,000 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

2,000

Conditions

Symptomatic Venous Thromboembolism (VTE)

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (9)

Sky Ridge Medical Center

Lone Tree, Colorado, United States

RECRUITING

Medical Research of Westchester - MPLUS Research Network

Miami, Florida, United States

RECRUITING

Phoenix Clinical Research

Tamarac, Florida, United States

RECRUITING

NextStage Clinical Research, St. Francis Medical Park

Wichita, Kansas, United States

RECRUITING

Sinai Hospital of Baltimore, Inc.

Baltimore, Maryland, United States

RECRUITING

Ohio Clinical Trials

Columbus, Ohio, United States

RECRUITING

HD Research - Memorial Hermann Village

Houston, Texas, United States

RECRUITING

Endeavor Clinical Trials

San Antonio, Texas, United States

RECRUITING

Spokane Joint Replacement Center

Spokane, Washington, United States

RECRUITING