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

Part of paid clinical trials in Amarillo, Texas.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07318610
Phase
PHASE3
Status
Recruiting
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Conditions

  • Peripheral Artery Disease (PAD)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN7508 — DRUG
    Administered per the protocol
  • REGN9933 — DRUG
    Administered per the protocol
  • Placebo — DRUG
    Administered per the protocol
  • Rivaroxaban — DRUG
    Administered per the protocol

Study Details

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

Key Dates

Start date
May 29, 2026
Status verified
May 2026
Primary completion
Aug 18, 2029
Completion
Nov 16, 2029

Study Design

Enrollment
7,050 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
  • Experimental: Cohort 2

Primary Outcome Measure

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 [ Time Frame: Approximately up to 42 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
PharmaTex ResearchAmarilloTexas79106-

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PharmaTex Research· Amarillo, TX

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