Vascular Trial Associated Registry Pilot: Antiplatelet Therapies for Patients Undergoing Lower Extremity Endovascular Revascularization
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- The proportion of patients eligible who are offered study enrollment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Clopidogrel (Plavix) Pharmacogenetic Test Reagents (Drug)
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).
干预措施: Clopidogrel (Plavix) Pharmacogenetic Test Reagents (Drug)
结局指标
主要结局
The proportion of patients eligible who are offered study enrollment
时间窗: 1 year
Patients who undergo PVI that meet inclusion criteria and are offered enrollment.
The proportion of eligible patients who consent to enrollment and randomization
时间窗: 1 year
Patients who meet inclusion criteria and agree to participate in trial vs those that do not agree to participate in trial
The proportion of enrolled patients who have the primary (composite) event of interest defined at 6 months
时间窗: 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.
The numbers and proportions of patients who have each type of major event
时间窗: 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.
The proportions of patients who have major event status recorded at each observation time
时间窗: 1 year
Major event status at 1, 6-months post PVI and 12-month post PVI
The proportion of enrolled patients who have the primary (composite) event of interest defined at 12 months
时间窗: 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.
次要结局
未报告次要终点
研究者
Vikram Kashyap
Vice President, Cardiovascular Health, Frederik Meijer Heart and Vascular Institute
Corewell Health West