Health Trials

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

ConditionSymptomatic Venous Thromboembolism (VTE)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • REGN7508

    Drug

    Administered per the protocol

  • Acetylsalicylic Acid (ASA)

    Drug

    Administered per the protocol

  • Placebo

    Drug

    Administered per the protocol

Treatment groups

2,000 Participants
are divided into 2 treatment groups
Group A: REGN7508 and PlaceboExperimental treatment 2 interventions
Group B: Placebo and ASAActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Incidence of the composite endpoint of symptomatic VTE and all-cause death

Time frame
Through day 30 visit

Secondary outcomes

1

Time to first event of the composite endpoint of symptomatic VTE and all-cause death

Time frame
Through day 30 visit
2

Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT)

Time frame
Through day 30 visit
3

Incidence of confirmed Pulmonary Embolism (PE)

Time frame
Through day 30 visit
4

Incidence of all-cause death

Time frame
Through day 30 visit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Regeneron Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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