Vascular Trial Associated Registry Pilot: Antiplatelet Therapies for Patients Undergoing Lower Extremity Endovascular Revascularization

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
United States
Michigan
Henry Ford Hospital
NOT_YET_RECRUITING
Detroit
Corewell Health
RECRUITING
Grand Rapids
Contact Information
Primary
Stephen C Orey, MS
Stephen.orey@corewellhealth.org
6163916660
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2028-10-30
Participants
Target number of participants: 350
Treatments
Active_comparator: Dual antiplatelet therapy 1-Month followed by single antiplatelet therapy indefinitely
Aspirin and Clopidogrel (Plavix) for 1-month post-procedure followed by Aspirin indefinitely.~Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (Plavix) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).
Active_comparator: Dual antiplatelet therapy 6-Month followed by single antiplatelet therapy indefinitely
Aspirin and Clopidogrel (Plavix) for 6-months post-procedure followed by Aspirin indefinitely.~Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (Plavix) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).
Sponsors
Leads: Corewell Health West
Collaborators: Henry Ford Hospital

This content was sourced from clinicaltrials.gov