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

Study acronym: ROXI-ASPEN
StatusRecruiting
PhasePhase 3
Started2025-11-24
View on ClinicalTrials.gov ↗

Amendment history

2026-09-10
Study Status, Contacts/Locations v13
Trial sites expanded: 36 → 46 locations
2026-08-17
Study Status, Contacts/Locations v12
Study sites32→34
2026-07-21
Study Status, Contacts/Locations v11
Trial sites expanded: 28 → 32 locations
2026-07-08
Study Status, Contacts/Locations v10
Trial sites expanded: 23 → 28 locations
2026-06-16
Study Status, Contacts/Locations v9
Trial sites expanded: 19 → 23 locations
2026-06-01
Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations v8
Primary endpoint(s) modified1 entry, revised
WasIncidence of the composite endpoint of symptomatic VTE and VTE-related death
NowIncidence of the composite endpoint of symptomatic VTE and all-cause death
Trial sites expanded: 16 → 19 locations
Secondary endpoints14 entries, revised
Incidence of VTE-related death Time to first event of the composite endpoint of symptomatic VTE and VTEall-relatedcause death Incidence of all-cause death Time to first event of the confirmed symptomatic DVT Time to first event of the confirmed PE Time to VTEthe all-relatedcause death
2026-05-04
Study Status, Contacts/Locations v7
Study sites14→16
2026-04-22
Study Status, Contacts/Locations v6
Study sites13→14
2026-04-07
Study Status, Contacts/Locations v5
Trial sites expanded: 10 → 13 locations
2026-03-16
Study Status, Contacts/Locations v4
Study sites9→10
2026-02-03
Study Status, Contacts/Locations v3
Study sites5→9
2026-01-21
Study Status, Contacts/Locations v2
Study sites2→5
2025-12-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2027-07-16→2027-05-17
Start dateestimated 2025-12-05→confirmed 2025-11-24
Study sites0→2
2025-10-03
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
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)
Trial Details
NCT Number NCT07213778
Lead Sponsor Regeneron Pharmaceuticals
Conditions Symptomatic Venous Thromboembolism (VTE)
Enrollment 2,000 participants
Start Date 2025-11-24
Primary Completion 2027-05-17 (estimated)
Study Completion 2027-07-16 (estimated)
Updated on ClinicalTrials.gov 2026-09-25