Vascular Trial Associated Registry Pilot

NCT ID: NCT07076082

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2028-10-30

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.

Detailed 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.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Clopidogrel (Plavix) Pharmacogenetic Test Reagents

Intervention Type: 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).

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).

Group Type: ACTIVE_COMPARATOR

Clopidogrel (Plavix) Pharmacogenetic Test Reagents

Intervention Type: 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).

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).

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henry Ford Hospital

OTHER

Sponsor Role: collaborator

Corewell Health West

OTHER

Sponsor Role: lead

Responsible Party

Vikram Kashyap

Vice President, Cardiovascular Health, Frederik Meijer Heart and Vascular Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vikram C Kashyap, MD

Role: PRINCIPAL_INVESTIGATOR

Corewell Health West

Locations

Henry Ford Hospital

Detroit, Michigan, United States

Site Status: NOT_YET_RECRUITING

Corewell Health

Grand Rapids, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Stephen C Orey, MS

Role: CONTACT

Stephen.orey@corewellhealth.org

6163916660

Facility Contacts

Sarah Meehan

Role: primary

smeehan1@hfhs.org

(313) 916-9387

Stephen C Orey, MS

Role: primary

Stephen.orey@corewellhealth.org

6163916660

References

Aday AW, Gutierrez JA. Antiplatelet Therapy Following Peripheral Arterial Interventions: The Choice Is Yours. Circ Cardiovasc Interv. 2020 Aug;13(8):e009727. doi: 10.1161/CIRCINTERVENTIONS.120.009727. Epub 2020 Aug 14. No abstract available.

Reference Type: BACKGROUND

PMID: 32791949 (View on PubMed)

Bhatt DL, Flather MD, Hacke W, Berger PB, Black HR, Boden WE, Cacoub P, Cohen EA, Creager MA, Easton JD, Hamm CW, Hankey GJ, Johnston SC, Mak KH, Mas JL, Montalescot G, Pearson TA, Steg PG, Steinhubl SR, Weber MA, Fabry-Ribaudo L, Hu T, Topol EJ, Fox KA; CHARISMA Investigators. Patients with prior myocardial infarction, stroke, or symptomatic peripheral arterial disease in the CHARISMA trial. J Am Coll Cardiol. 2007 May 15;49(19):1982-8. doi: 10.1016/j.jacc.2007.03.025. Epub 2007 Apr 11.

Reference Type: BACKGROUND

PMID: 17498584 (View on PubMed)

Durand-Zaleski I, Bertrand M. The value of clopidogrel versus aspirin in reducing atherothrombotic events: the CAPRIE study. Pharmacoeconomics. 2004;22 Suppl 4:19-27. doi: 10.2165/00019053-200422004-00005.

Reference Type: BACKGROUND

PMID: 15876009 (View on PubMed)

Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR; Peer Review Committee Members. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2024 Jun 11;149(24):e1313-e1410. doi: 10.1161/CIR.0000000000001251. Epub 2024 May 14.

Reference Type: BACKGROUND

PMID: 38743805 (View on PubMed)

Writing Committee Members; Gornik HL, Aronow HD, Goodney PP, Arya S, Brewster LP, Byrd L, Chandra V, Drachman DE, Eaves JM, Ehrman JK, Evans JN, Getchius TSD, Gutierrez JA, Hawkins BM, Hess CN, Ho KJ, Jones WS, Kim ESH, Kinlay S, Kirksey L, Kohlman-Trigoboff D, Long CA, Pollak AW, Sabri SS, Sadwin LB, Secemsky EA, Serhal M, Shishehbor MH, Treat-Jacobson D, Wilkins LR. 2024 ACC/AHA/AACVPR/APMA/ABC/SCAI/SVM/SVN/SVS/SIR/VESS Guideline for the Management of Lower Extremity Peripheral Artery Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2024 Jun 18;83(24):2497-2604. doi: 10.1016/j.jacc.2024.02.013. Epub 2024 May 14.

Reference Type: BACKGROUND

PMID: 38752899 (View on PubMed)

Tsai SY, Li YS, Lee CH, Cha SW, Wang YC, Su TW, Yu SY, Yeh CH. Mono or Dual Antiplatelet Therapy for Treating Patients with Peripheral Artery Disease after Lower Extremity Revascularization: A Systematic Review and Meta-Analysis. Pharmaceuticals (Basel). 2022 May 12;15(5):596. doi: 10.3390/ph15050596.

Reference Type: BACKGROUND

PMID: 35631422 (View on PubMed)

Nguyen T, Jokisch C, Dargan C, Janjua H, Brooks J, Moudgill N, Latz C, Shames M. The Effects of Clopidogrel Duration on Carotid Artery In-Stent Restenosis. Ann Vasc Surg. 2024 Jun;103:68-73. doi: 10.1016/j.avsg.2023.12.064. Epub 2024 Feb 11.

Reference Type: BACKGROUND

PMID: 38350539 (View on PubMed)

Other Identifiers

2025-1010

Identifier Type: -

Identifier Source: org_study_id