Vascular Trial Associated Registry Pilot
Recruiting now · Phase 4
Conditions studied: Peripheral Arterial Disease
In brief
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.
Key facts
- Study ID
- NCT07076082
- Run by
- Corewell Health West
- People needed
- 350
- Starts
- 2025-10-15
- Expected to finish
- 2028-10-30
- Last updated by the study team
- 2026-07-16
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You 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 may not qualify 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
Where it is running
- Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
- Corewell Health West — Grand Rapids, Michigan, United States (enrolling)
Full record on ClinicalTrials.gov
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