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NCT07318610From ClinicalTrials.govRecruiting

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

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)

  • Peripheral Artery Disease (PAD)

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Regeneron Pharmaceuticals
Enrolment target
7,050
Started
10 July 2026
Main results due
18 August 2029
Study sites
20
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(20)

  • Lake Martin Medical and Vascular Center

    Alexander City, Alabama, United States

    Recruiting

  • Axsendo Clinical Research, Integrated Medical Services

    Avondale, Arizona, United States

    Recruiting

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, United States

    Recruiting

  • Angel City Research, Inc.

    Los Angeles, California, United States

    Recruiting

  • Pacific Cardiovascular and Vein Institute

    Oxnard, California, United States

    Recruiting

  • Interventional Cardiology Medical Group

    West Hills, California, United States

    Recruiting

  • Nature Coast Clinical Research - Cardiology

    Crystal River, Florida, United States

    Recruiting

  • Cardiovascular Institute of Northwest Florida, Main Office

    Panama City, Florida, United States

    Recruiting

  • Tampa Cardiovascular Interventions and Research

    Tampa, Florida, United States

    Recruiting

  • Profound Research, Powers Health Medical Group

    Munster, Indiana, United States

    Recruiting

  • Cardiovascular Solutions

    Shreveport, Louisiana, United States

    Recruiting

  • Accellacare of Piedmont, Piedmont Healthcare

    Mooresville, North Carolina, United States

    Recruiting

  • Hightower Clinical

    Oklahoma City, Oklahoma, United States

    Recruiting

  • Apex Research Foundation, LLC

    Jackson, Tennessee, United States

    Recruiting

  • Tennova TCMC

    Knoxville, Tennessee, United States

    Recruiting

  • Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular Associates

    Tullahoma, Tennessee, United States

    Recruiting

  • PharmaTex Research

    Amarillo, Texas, United States

    Recruiting

  • Vital Heart and Vein

    Cypress, Texas, United States

    Recruiting

  • Epic Medical Research

    DeSoto, Texas, United States

    Recruiting

  • Epic Medical Research-Plano

    Plano, Texas, United States

    Recruiting

Showing 20 of 20 sites. 20 of the 20 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07318610. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Dise | Trialion