Clinical trial for Peripheral Artery Disease (PAD)
Official title Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
ClinicalTrials.gov ID: NCT07318610
What this study is testing
What is REGN7508?
an investigational drug being studied to prevent life‑threatening blood clots in people with peripheral artery disease after lower‑extremity revascularization
Also referred to as cenvacibart.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to see if two new drugs can prevent serious blood clots in people who have had leg surgery. It also compares these drugs to a standard blood thinner and a placebo.
- Who it's for
- The study is looking for adults with Peripheral Artery Disease (narrowed blood vessels in the legs) who recently had surgery to improve blood flow.
- What's involved
- Participants will take one of the study drugs, a standard blood thinner, or a placebo. They will have regular check-ups and blood tests to monitor safety and how the drug works in the body.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in...
- Bypass with prosthetic graft
- Endovascular treatment with stenting
- Target lesion length \>15 cm
- History of LER or amputation for PAD prior to qualifying LER
You likely can't join if
- Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive...
- Has known bleeding diathesis, platelet count \<50,000/mm\^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy...
- Has recent coronary revascularization as described in the protocol
- 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...
- Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study...
- Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients Note: Other...
See the full eligibility criteria
- 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
- Bypass with prosthetic graft
- Endovascular treatment with stenting
- Target lesion length \>15 cm
- History of LER or amputation for PAD prior to qualifying LER
- Type 2 diabetes mellitus requiring pharmacologic treatment
- Comorbid symptomatic coronary artery disease as described in the protocol
- Chronic kidney disease as described in the protocol
- Age ≥75 years Key
- Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome
- 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
- Has recent coronary revascularization as described in the protocol
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Alexander City, Alabama, United States
- Avondale, Arizona, United States
- Little Rock, Arkansas, United States
- Los Angeles, California, United States
- Oxnard, California, United States
- West Hills, California, United States
- Crystal River, Florida, United States
- Jacksonville, Florida, United States
- Miami Lakes, Florida, United States
- Panama City, Florida, United States
- Tampa, Florida, United States
- Fort Wayne, Indiana, United States
- Hammond, Indiana, United States
- Munster, Indiana, United States
- Shreveport, Louisiana, United States
- Petal, Mississippi, United States
- Flemington, New Jersey, United States
- Valhalla, New York, United States
- Charlotte, North Carolina, United States
- Mooresville, North Carolina, United States
+ 11 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Alexander City, Alabama, United States; Avondale, Arizona, United States; Little Rock, Arkansas, United States; Los Angeles, California, United States; Oxnard, California, United States; West Hills, California, United States and 25 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.