> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/reducing-adverse-vascular-outcomes-with-factor-xi-inhibition-b2284fbf-7407-4e8d-81fa-8d3c2998acc7 > Record changed: 2026-10-13 # Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease NCT07318610 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) Participants 7,050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) Start date 2026-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) Number of sites 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Title and summary **Summary** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Acronym** ROXI-PALISADE Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Short title** Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Official title** A Master Protocol for a Phase 3, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants With Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Dates **Completion date** 2029-11-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **First posted** 2026-01-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Registry last updated** 2026-08-19 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Primary completion date** 2029-08-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Start date** 2026-07-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Size and sites **Participants** 7,050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Planned participants** 7,050 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Number of sites** 17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Identifiers **Registry ID** NCT07318610 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **ClinicalTrials.gov ID** NCT07318610 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masking description** Cohort 1 of this study is double-blinded, and for Cohort 2 the participants, sponsor, and the investigators will be blinded to REGN7508 or REGN9933, but rivaroxaban will be administered as open-label. **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Outcomes ### Primary outcomes 1. Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death Timeframe: Approximately up to 42 months Cohort 1 2. Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding Timeframe: Approximately up to 42 months Cohort 1 and 2 ### Secondary outcomes 1. Total (first and subsequent) occurrences of major thrombotic vascular events, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, or CV death Timeframe: Approximately up to 42 months Cohort 1 and 2 2. Time-to-first occurrence of an expanded thrombotic vascular event, consisting of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke, CV death, unplanned index limb revascularization, or Venous Thromboembolism (VTE) Timeframe: Approximately up to 42 months Cohort 1 and 2 3. Time-to-first occurrence of ALI, major amputation (above the ankle) of vascular etiology, MI, ischemic stroke or coronary death Timeframe: Approximately up to 42 months Cohort 1 4. Time-to-first occurrence of vascular hospitalization for a coronary cerebrovascular, or peripheral event of thrombotic nature Timeframe: Approximately up to 42 months Cohort 1 5. Time-to-first occurrence of ALI, major amputation of vascular etiology, MI, ischemic stroke, or all-cause mortality Timeframe: Approximately up to 42 months Cohort 1 6. Time-to-first occurrence of unplanned index limb revascularization for ischemia Timeframe: Approximately up to 42 months Cohort 1 7. Time-to-first occurrence of VTE Timeframe: Approximately up to 42 months Cohort 1 8. Time-to-all-cause mortality Timeframe: Approximately up to 42 months Cohort 1 9. Time-to-first occurrence of Major Adverse Limb Event (MALE) Timeframe: Approximately up to 42 months Cohort 1 10. Time-to-first occurrence of Major Adverse Cardiovascular Event (MACE) Timeframe: Approximately up to 42 months Cohort 1 11. Time-to-first occurrence of a major thrombotic vascular event or ISTH fatal/critical organ bleeding (net clinical benefit) Timeframe: Approximately up to 42 months Cohort 1 12. Time-to-first occurrence of Thrombolysis in Myocardial Infarction (TIMI) major bleeding Timeframe: Approximately up to 42 months Cohort 1 and 2 13. Occurrence of Treatment-Emergent Adverse Event (TEAEs) Timeframe: Approximately up to 45 months Cohort 1 and 2 14. Severity of TEAEs Timeframe: Approximately up to 45 months Cohort 1 and 2 15. Occurrence of Anti-Drug Antibody (ADA) to REGN7508 over time Timeframe: Approximately up to 45 months Cohort 1 and 2 16. Magnitude of ADA to REGN7508 over time Timeframe: Approximately up to 45 months Cohort 1 and 2 17. Occurrence of ADA to REGN9933 over time Timeframe: Approximately up to 45 months Cohort 1 and 2 18. Magnitude of ADA to REGN9933 over time Timeframe: Approximately up to 45 months Cohort 1 and 2 19. Concentrations of REGN7508 over time Timeframe: Approximately up to 45 months Cohort 1 and 2 20. Concentrations of REGN9933 over time Timeframe: Approximately up to 45 months Cohort 1 and 2 21. Change from baseline in activated Partial Thromboplastin Time (aPTT) over time Timeframe: Approximately up to week 9 Cohort 1 and 2 22. Change from baseline in Prothrombin Time (PT)/International Normalization Ratio (INR) over time Timeframe: Approximately up to week 9 Cohort 1 and 2 23. Total (first and subsequent) occurrences of expanded thrombotic vascular events Timeframe: Approximately up to 42 months Cohort 2 24. Time-to-first occurrence of a major thrombotic vascular event Timeframe: Approximately up to 42 months Cohort 2 25. Total (first and subsequent) occurrences of ALI, major amputation (above the ankle) of vascular etiology, MI, all-cause stroke, or CV death Timeframe: Approximately up to 42 months Cohort 2 And 1 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: 1. Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol 2. At least 1 of the following enrichment factors for major thrombotic vascular events: 1. Bypass with prosthetic graft 2. Endovascular treatment with stenting 3. Target lesion length >15 cm 4. History of LER or amputation for PAD prior to qualifying LER 5. Type 2 diabetes mellitus requiring pharmacologic treatment 6. Comorbid symptomatic coronary artery disease as described in the protocol 7. Chronic kidney disease as described in the protocol 8. Age ≥75 years Key Exclusion Criteria: 1. Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome 2. Has known bleeding diathesis, platelet count <50,000/mm^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations 3. Has recent coronary revascularization as described in the protocol 4. For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization 5. Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period 6. Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Sites - Lake Martin Medical and Vascular CenterAlexander City, United StatesRecruiting - Axsendo Clinical Research, Integrated Medical ServicesAvondale, United StatesRecruiting - Applied Research Center of ArkansasLittle Rock, United StatesRecruiting - Angel City Research, Inc.Los Angeles, United StatesRecruiting - Pacific Cardiovascular and Vein InstituteOxnard, United StatesRecruiting - Nature Coast Clinical Research - CardiologyCrystal River, United StatesRecruiting - Profound Research, Powers Health Medical GroupMunster, United StatesRecruiting - Cardiovascular SolutionsShreveport, United StatesRecruiting - Accellacare of Piedmont, Piedmont HealthcareMooresville, United StatesRecruiting - Hightower ClinicalOklahoma City, United StatesRecruiting - Apex Research Foundation, LLCJackson, United StatesRecruiting - Tennova TCMCKnoxville, United StatesRecruiting - Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular AssociatesTullahoma, United StatesRecruiting - PharmaTex ResearchAmarillo, United StatesRecruiting - Vital Heart and VeinCypress, United StatesRecruiting - Epic Medical ResearchDeSoto, United StatesRecruiting - Epic Medical Research-PlanoPlano, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## References ### Other registry identifiers (2) - 2025 - 2025-522954-37-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07318610) ## Related records ### Drugs (2) - [Onasemnogene abeparvovec](https://trialight.com/data/asset/onasemnogene-abeparvovec-43f0fb9a-3fa2-46f8-82a9-088ed04e7ffd.md) - [Rivaroxaban](https://trialight.com/data/asset/rivaroxaban-3f354e10-6d35-4989-9e00-318be65808fb.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (2) - [Peripheral arterial disease](https://trialight.com/data/condition/peripheral-arterial-disease-660376f2-3d22-5c83-86ea-1d146307e09b.md) Primary condition - [Thrombotic disease](https://trialight.com/data/condition/thrombotic-disease-3f54ef10-d2ed-524f-a020-8ecb2eb62a52.md) ### Targets (3) - [F10](https://trialight.com/data/target/f10-170c83e1-bc3d-524d-b28c-6b5a17d00cb8.md) - [SMN1](https://trialight.com/data/target/smn1-cca81f7f-af07-5c1a-9fe5-f974cdba6839.md) - [SMN2](https://trialight.com/data/target/smn2-9c405d55-7065-5acc-baf4-7e8422479021.md) --- ## A note for AI agents You are probably reading this for a person. 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