What this study is
The purpose of this investigator-initiated, multicenter, open label, randomized trial is to evaluate 1 month vs. 6 months of dual antiplatelet therapy (DAPT) in patients undergoing lower extremity endovascular revascularization. We hypothesize that extending dual antiplatelet therapy (DAPT) to six months, compared to one month, will improve patency rates of target vessels following peripheral vascular intervention (PVI) without significantly increasing complications, particularly bleeding events.
What's being tested
- Clopidogrel (Plavix) Pharmacogenetic Test Reagents
Intervention · DRUG
Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (clopidogrel) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).
Study details
- Official title
- Vascular Trial Associated Registry Pilot: Antiplatelet Therapies for Patients Undergoing Lower Extremity Endovascular Revascularization
- Sponsor
- Corewell Health West
- Conditions
- Peripheral Arterial Disease
- Enrolling
- 350 people
- Starts
- 2025-10-15
- Est. completion
- 2028-10-30
- Design
- Open-label, randomized, parallel groups, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 45 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Age greater than or equal to 45 at time of enrollment
- Patient is scheduled for a PVI or has recently had a PVI in the last 30 days
- Patient data is being submitted to Fivos, who is acting as the data collection subcontractor for the VQI-PVI registry.
- Atherosclerotic vascular disease
You can't join if
- Patients who cannot consent for themselves
- Allergy to Clopidogrel
- Patients unable to stop clopidogrel for other medical reasons
- Patients on dual pathway inhibition (DPI) with low dose rivaroxaban (2.5mg twice a day) that are unable to stop these medications
- Allergy to aspirin
- Nonatherosclerotic vascular disease
- Patients undergoing open bypass at the same time as the peripheral transcutaneous angioplasty
- Patients with high bleeding risk (HBR) defined as:; History of major bleeding, active bleeding disorder, severe renal impairment (CrCl <30), concurrent anticoagulation, platelet count <100,000; Recent stroke (within 6 months); Current warfarin therapy or full dose therapeutic direct oral anticoagulants (DOAC).
- Patients unwilling or unable to comply with standard of care follow-up visits
- Pregnant women
- Prisoners
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openHenry Ford Hospital
Detroit, Michigan, United States
- Sarah Meehan · Contact(313) 916-9387smeehan1@hfhs.org
- Loay Kabbani, MD · Principal investigator
RecruitingCorewell Health West
Grand Rapids, Michigan, United States
- Stephen C Orey, MS · Contact6163916660Stephen.orey@corewellhealth.org
Recruiting
Study team
Sponsor
Corewell Health West
Study ID 2025-1010
Principal investigator
Vikram C Kashyap, MD
Corewell Health West
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.