Early Initiation of Antiplatelet ThERapy In HeArt TranspLantation: AERIAL Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 135
- 试验地点
- 6
- 主要终点
- Feasibility: Recruitment rate
研究概览
简要总结
Cardiac allograft vasculopathy is a common complication affecting heart transplant patients. This condition causes narrowing of the heart arteries leading to graft dysfunction. The research team is investigating whether early antiplatelet therapy post heart transplant can prevent the development of CAV. This study will determine the feasibility of a large multicenter randomized placebo-controlled trial to answer this question.
详细描述
Heart transplant patients who fulfill selection criteria will undergo baseline clinical evaluation and data collection. Participants will be randomized to either placebo, aspirin or clopidogrel to be taken daily for the duration of the study. Patients will undergo invasive coronary studies (angiography, optical coherence tomography and intracoronary flow) and platelet function testing at 2 and 12 months post heart transplant. In addition, angiography will be performed at 24 months post heart transplant and thereafter according to institutional protocol. The primary analysis will determine the feasibility of conducting a large multicenter randomized placebo controlled trial by assessing recruitment rates, event rates, treatment crossovers and loss to follow-up. Secondary analyses will include assessing the effect of antiplatelet treatment on angiographic CAV, coronary intimal disease on optical coherence tomography, coronary macrovascular and microvascular function by intracoronary flow measures, and platelet function.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patients, clinical care providers and research staff will be blinded to treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Heart transplant
- •Age ≥18 years
- •Able to provide informed consent
排除标准
- •Allergy or known intolerance to aspirin
- •Allergy or known intolerance to clopidogrel
- •Intracranial hemorrhage ≤14 days
- •Bleeding disorder
- •Platelet count <50 x 109/L
- •History of aspirin related gastrointestinal bleeding or ulcers
- •Non-cardiac indication for antiplatelet therapy
- •Anticoagulation >3 months
- •Allergy to iodinated contrast
- •Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m2 for non-dialysis patients
- •Unable to undergo coronary angiography due to unsuitable vascular access
- •Combined solid organ transplantation.
研究组 & 干预措施
clopidogrel
干预措施: Clopidogrel (Drug)
aspirin
干预措施: aspirin (Drug)
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Feasibility: Recruitment rate
时间窗: 3 years
Average recruitment rate of 4.5 patients per month at 3 study sites
Feasibility: CAV event rate
时间窗: 3 years
2-year CAV event rate of \>8%
Feasibility: Treatment cross over rate
时间窗: 3 years
Crossover from aspirin to placebo \<2%, clopidogrel to placebo \<2%, placebo to aspirin \<4%, placebo to clopidogrel \<1%
Feasibility: Loss to follow up rate
时间窗: 3 years
Loss-to-follow-up \<1%
Feasibility: Compliance to treatment
时间窗: 3 years
Compliance to treatment \>80%
次要结局
- Cardiac allograft vasculopathy(1 and 2 years post transplant)
- Coronary intimal disease(2 months, 1 year post transplant)
- Coronary endothelial function(2 months and 1 year post transplant)
- Coronary macrovascular function(2 months and 1 year post transplant)
- Coronary microvascular function(2 months and 1 year post transplant)
- Platelet Function(Baseline, 2 months and 1 year post transplant)