Recruiting

DAPT

Sponsor:

Corewell Health West

Code:

NCT07076082

Conditions

Peripheral Arterial Disease

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Clopidogrel (Plavix) Pharmacogenetic Test Reagents

Study Details

Brief 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.

Conditions

Peripheral Arterial Disease

Study ID

NCT07076082

Start date

Oct 15, 2025

Status verified date

Jul, 2026

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Oct 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

350 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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).

Interventions

Clopidogrel (Plavix) Pharmacogenetic Test Reagents

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).

Primary outcome measure

  • The proportion of patients eligible who are offered study enrollment [ Time Frame: 1 year ]
  • The proportion of eligible patients who consent to enrollment and randomization [ Time Frame: 1 year ]
  • The proportion of enrolled patients who have the primary (composite) event of interest defined at 6 months [ Time Frame: 6-months ]
  • The proportion of enrolled patients who have the primary (composite) event of interest defined at 12 months [ Time Frame: 1 year ]
  • The numbers and proportions of patients who have each type of major event [ Time Frame: 1 year ]
  • The proportions of patients who have major event status recorded at each observation time [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Stephen C Orey, MS

6163916660Stephen.orey@corewellhealth.org

Locations

Henry Ford Hospital

Recruiting

Detroit, Michigan, United States, 48202-2608

Contacts

Sarah Meehan

(313) 916-9387smeehan1@hfhs.org

Principal Investigator:

Loay Kabbani, MD

Corewell Health West

Recruiting

Grand Rapids, Michigan, United States, 49503

Contacts

Stephen C Orey, MS

6163916660Stephen.orey@corewellhealth.org

More Information

Sponsor

Corewell Health West

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

  • Peripheral Vascular Disease (PVD), Peripheral Vascular Intervention (PVI), Dual Antiplatelet therapy (DAPT), Peripheral Arterial Disease (PAD)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Corewell Health West on 2026-07-16.