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Clinical Trials in Spain / NCT07213778
Recruiting Phase 3

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

NCT07213778 · tracked via the Priya Life Science Spain tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 3
Started
2025-11-24
Last updated
2026-10-08

Condition(s) studied

Symptomatic Venous Thromboembolism (VTE)

Investigational drug(s) / intervention(s)

REGN7508 →Acetylsalicylic Acid (ASA) →Placebo

REGN7508: Administered per the protocol

Acetylsalicylic Acid (ASA): Administered per the protocol

Placebo: Administered per the protocol

Study summary

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Incidence of the composite endpoint of symptomatic VTE and all-cause death — Through day 30 visit

Trial sites (49)

FacilityCityRegionStatus
Horizon Clinical Research La Mesa California Recruiting
Eisenhower Medical Center Rancho Mirage California Recruiting
CARI Clinical Trials Riverside California Recruiting
Sky Ridge Medical Center Lone Tree Colorado Recruiting
South Florida Joint Replacement Center Deerfield Beach Florida Recruiting
Delray Physician Care Center Delray Beach Florida Recruiting
Medical Research of Westchester - MPLUS Research Network Miami Florida Recruiting
Larkin Community Hospital South Miami South Miami Florida Recruiting
Phoenix Clinical Research Tamarac Florida Recruiting
Endeavor Health Skokie Illinois Recruiting
The Orthopaedic Research Foundation, Inc. Indianapolis Indiana Recruiting
NextStage Clinical Research, St. Francis Medical Park Wichita Kansas Recruiting
Velocity Clinical Research, Annapolis Annapolis Maryland Recruiting
Sinai Hospital of Baltimore, Inc. Baltimore Maryland Recruiting
Tufts Medical Center Boston Massachusetts Recruiting
Boston Medical Center Boston Massachusetts Recruiting
Holy Name Medical Center Teaneck New Jersey Recruiting
Northwell Orthopaedic Institute New York New York Recruiting
University of Rochester Medical Center Rochester New York Recruiting
UBMD Orthopaedics and Sports Medicine Williamsville New York Recruiting
Atrium Health Musculoskeletal Institute and Sports Medicine Charlotte North Carolina Recruiting
Duke University Health System (Duke Health), Duke University Hospital Durham North Carolina Recruiting
Eximia Equihealth Research-Raleigh. LLC Raleigh North Carolina Recruiting
The Vein and Vascular Center at Raleigh Radiology Raleigh North Carolina Recruiting
Coastal Vascular Institute, PA Wilmington North Carolina Recruiting
University of Cincinnati Cincinnati Ohio Recruiting
The Ohio State University Wexner Medical Center Columbus Ohio Recruiting
Ohio Clinical Trials Columbus Ohio Recruiting
Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania Recruiting
University of Pittsburgh Pittsburgh Pennsylvania Recruiting
HD Research - Memorial Hermann Village Houston Texas Completed
NextStage Clinical Research, All American Orthopedics and Sports Medicine Houston Texas Recruiting
Flourish Research - San Antonio (Formerly Clinical Trials of Texas) San Antonio Texas Recruiting
Endeavor Clinical Trials San Antonio Texas Withdrawn
Carilion Clinic Roanoke Virginia Recruiting
Spokane Joint Replacement Center Spokane Washington Recruiting
Henry Dunant Hospital Center Athens Attica Recruiting
National and Kapodistrian University of Athens, General Hospital of Nea Ionia Konstantopouleio Patision Nea Ionia Attica Recruiting
Sultan Abdul Halim Hospital Sungai Petani Kedah Recruiting
Hospital Pakar Universiti Sains Malaysia Kota Bharu Kelantan Recruiting

+ 9 more sites — see the full list on the official registry below.

More Regeneron Pharmaceuticals trials in Spain

A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies Active, not recruiting
Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma Active, not recruiting
A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Whose Current Treatment is Not Working Efficiently Recruiting
A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment Active, not recruiting
A Study to Learn if a Combination of Fianlimab and Cemiplimab Versus Cemiplimab Alone is More Effective for Adult Participants With Advanced Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07213778 on ClinicalTrials.gov ↗ ← All trials in Spain