Vascular Trial Associated Registry Pilot

Conditions

• Peripheral Arterial Disease

Eligibility Criteria

Sex

ALL

Age

45 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Clopidogrel (Plavix) Pharmacogenetic Test Reagents — 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

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 Dates

Start date

Oct 15, 2025

Status verified

Apr 2026

Primary completion

Oct 30, 2027

Completion

Oct 30, 2028

Study Design

Enrollment

350 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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).

Primary Outcome Measure

The proportion of patients eligible who are offered study enrollment [ Time Frame: 1 year ]

Central Contacts

• Stephen C Orey, MS
  6163916660
  [email protected]

Locations (2)

Find similar trials in Detroit, MI

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