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Recruiting NCT07213778

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

Phase III Interventional Symptomatic Venous Thromboembolism (VTE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REGN7508, Acetylsalicylic Acid (ASA), Placebo.
Who it may be relevant to
Registry conditions: Symptomatic Venous Thromboembolism (VTE). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Greece, Malaysia, Moldova
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 3, Multicenter, Double-Blinded, Randomized Study to Evaluate REGN7508, a Factor XI Monoclonal Antibody, Versus Acetylsalicylic Acid for Prophylaxis of Symptomatic Venous Thromboembolism After Elective Total Knee Arthroplasty (ROXI-ASPEN)

Overview

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)

Interventions

  • Drug REGN7508
    Administered per the protocol
  • Drug Acetylsalicylic Acid (ASA)
    Administered per the protocol
  • Drug Placebo
    Administered per the protocol

Primary outcome measures

  • Incidence of the composite endpoint of symptomatic VTE and all-cause death [Time frame: Through day 30 visit]
Secondary outcome measures (12)
  • Time to first event of the composite endpoint of symptomatic VTE and all-cause death [Time frame: Through day 30 visit]
  • Incidence of confirmed symptomatic Deep Vein Thrombosis (DVT) [Time frame: Through day 30 visit]
  • Incidence of confirmed Pulmonary Embolism (PE) [Time frame: Through day 30 visit]
  • Incidence of all-cause death [Time frame: Through day 30 visit]
  • Time to first event of the confirmed symptomatic DVT [Time frame: Through day 30 visit]
  • Time to first event of the confirmed PE [Time frame: Through day 30 visit]
  • Time to the all-cause death [Time frame: Through day 30 visit]
  • Incidence of the composite endpoint of major bleeding and Clinically Relevant Non-Major (CRNM) bleeding [Time frame: Through day 30 visit]
  • Incidence of minor bleeding [Time frame: Through day 30 visit]
  • Incidence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Through day 90 visit]
  • Severity of TEAEs [Time frame: Through day 90 visit]
  • Incidence of Anti-drug Antibody (ADA) to REGN7508 [Time frame: Through day 90 visit]

Eligibility criteria

Inclusion criteria

  • Is undergoing a primary elective unilateral TKA
  • 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
  • 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
  • Has received or plans to receive preoperative enoxaparin on the day prior to TKA surgery

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 28 centers
  • Horizon Clinical Research — La Mesa
  • Eisenhower Medical Center — Rancho Mirage
  • Sky Ridge Medical Center — Lone Tree
  • South Florida Joint Replacement Center — Deerfield Beach
  • Medical Research of Westchester - MPLUS Research Network — Miami
  • Phoenix Clinical Research — Tamarac
  • Endeavor Health — Skokie
  • The Orthopaedic Research Foundation, Inc. — Indianapolis
  • … and 20 more centers
Malaysia · 2 centers
  • Sultan Abdul Halim Hospital — Sungai Petani
  • Hospital Tengku Ampuan Afzan (HTTA) — Kuantan
Greece · 1 center
  • Henry Dunant Hospital Center — Athens
Moldova · 1 center
  • PMSI Emergency Medicine Institute — Chisinau

Identifiers

NCT: NCT07213778 · R7508-DVT-24120 · 2025-520479-25-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗