Vascular Trial Associated Registry Pilot

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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).

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• Henry Ford Hospital — Detroit
• Corewell Health West — Grand Rapids

Публикации

• 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. PMID 32791949
• 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 PMID 17498584
• 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. PMID 15876009
• 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/ PMID 38743805
• 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/ PMID 38752899
• 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. PMID 35631422
• 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. PMID 38350539

Идентификаторы

NCT: NCT07076082 · 2025-1010

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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