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NCT Number: NCT07076082

Vascular Trial Associated Registry Pilot

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Henry Ford Hospital, Detroit, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. The proportion of patients eligible who are offered study enrollment

    Time frame: 1 year

    Patients who undergo PVI that meet inclusion criteria and are offered enrollment.

  2. The proportion of eligible patients who consent to enrollment and randomization

    Time frame: 1 year

    Patients who meet inclusion criteria and agree to participate in trial vs those that do not agree to participate in trial

  3. The proportion of enrolled patients who have the primary (composite) event of interest defined at 6 months

    Time frame: 6-months

    The number of enrolled patients that have the occurrence of one of the following stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.

  4. The proportion of enrolled patients who have the primary (composite) event of interest defined at 12 months

    Time frame: 1 year

    The number of enrolled patients that have the occurrence of one of the following stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.

  5. The numbers and proportions of patients who have each type of major event

    Time frame: 1 year

    Of the enrolled patients that have a medical primary event how many individuals were in each category stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.

  6. The proportions of patients who have major event status recorded at each observation time

    Time frame: 1 year

    Major event status at 1, 6-months post PVI and 12-month post PVI

Study contacts

Contact information is provided by the study sponsor or research team.

Stephen C Orey, MS

CONTACT

[email protected]

6163916660

Sponsors and collaborators

Lead sponsor

Corewell Health West

Other

Collaborators

  • Henry Ford Hospital

Registry information

Official study title

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

Acronym: VSTAR-P

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jul 21, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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