Vascular Trial Associated Registry Pilot (VSTAR-P)

Corewell Health West

Status and phase: Enrolling; Phase 4

Conditions: Peripheral Arterial Disease

Treatments: Drug: Clopidogrel (Plavix) Pharmacogenetic Test Reagents

Study type: Interventional

Funder types: Other

Identifiers

NCT07076082

2025-1010

Details and patient eligibility

About

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.

Full description

The Main Objective of this study is to create an investigator-initiated, multicenter, open label, randomized trial to evaluate 1 month vs. 6 months of DAPT in patients undergoing lower extremity endovascular revascularization. The randomization will be 1:1 within one strata (diabetes yes/no), using blocks of varying sizes. All patients will be on DAPT for one month. At the time of the one-month visit, eligible patients who consent will be randomized to single antiplatelet therapy (SAPT) indefinitely (Arm 1) or to DAPT for 5 more months (followed by SAPT) (Arm 2). Follow-up will continue for 12-months post-procedure and will include assessment of MACE and MALE, as well as adverse bleeding events. Data for this trial will be collected via nested participation in the VQI Peripheral Vascular Intervention (PVI) registry's existing Procedural and Follow-up data collection modules.

Enrollment: 350 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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350 participants in 2 patient groups

Dual antiplatelet therapy 1-Month followed by single antiplatelet therapy indefinitely

Active Comparator group

Description:

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).

Treatment:

Drug: Clopidogrel (Plavix) Pharmacogenetic Test Reagents

Dual antiplatelet therapy 6-Month followed by single antiplatelet therapy indefinitely

Active Comparator group

Description:

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).

Treatment:

Drug: Clopidogrel (Plavix) Pharmacogenetic Test Reagents