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Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease

Study acronym: ROXI-PALISADE
StatusRecruiting
PhasePhase 3
Started2026-07-10
View on ClinicalTrials.gov ↗

Amendment history

2026-09-26
Trial sites expanded: 17 → 20 locations
2026-08-17
Study Status, Contacts/Locations v6
Trial sites expanded: 13 → 17 locations
2026-08-03
Study Status, Contacts/Locations v5
Study sites11→13
2026-07-30
Study Status, Contacts/Locations v4
Start dateestimated 2026-07-30→confirmed 2026-07-10
Study sites9→11
2026-07-09
Study Status, Contacts/Locations v3
Trial sites expanded: 4 → 9 locations
Start date2026-05-29→2026-07-30
2026-06-15
Study Status, Contacts/Locations v2
Trial sites expanded: 1 → 4 locations
2026-05-19
Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v1
Recruitment opened
Primary completion pushed: 2029-05-05 → 2029-08-18
Completion pushed: 2029-08-03 → 2029-11-16
Start date2026-03-31→2026-05-29
Study sites0→1
Eligibility criteria+51 characters
[...] or to randomization as described in the protocol At least 1 of the following enrichment factorfactors for major thrombotic vascular events: Bypass with prostheti [...] prior to qualifying LER Type 2 diabetes mellitus requiring pharmacologic treatment Comorbid symptomatic coronary artery disease as de [...] lusion Criteria: Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularizati [...] ization as described in the protocol For Cohort 2 only: Has estimated Glomerular Filtration Rate (GFReGFR) <15 mL/min/1.73m^2 within 14 days prior to randomization o [...]
Secondary endpoints26 entries, revised
Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature
2026-01-02
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
This study is researching 2 different experimental drugs called REGN7508 and REGN9933. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become too narrow. People with PAD have a higher risk of getting blood clots after procedures like Lower Extremity Revascularization (LER), a procedure to improve blood flow in the legs and feet. The aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The effects of REGN7508 and REGN9933, individually, will also be compared to rivaroxaban and a placebo. The study is looking at several other research questions, including: * What side effects might happen from taking the study drugs and how do they compare to the side effects of rivaroxaban * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * If the study drugs affect the ability of the blood to clot normally
Trial Details
NCT Number NCT07318610
Lead Sponsor Regeneron Pharmaceuticals
Conditions Peripheral Artery Disease (PAD)
Enrollment 7,050 participants
Start Date 2026-07-10
Primary Completion 2029-08-18 (estimated)
Study Completion 2029-11-16 (estimated)
Updated on ClinicalTrials.gov 2026-09-25