REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals
About this trial
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 criteria
Qualifiers
Is undergoing a primary elective unilateral TKA
Is in good health based on laboratory safety testing as described in the protocol
Disqualifiers
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
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)
History of thromboembolic disease or thrombophilia
History of platelet dysfunction
Trial design
Treatments tested in this trial
- REGN7508
- Acetylsalicylic Acid (ASA)
- Placebo
Treatment groups
2,000 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov