Assessment of Revascularization Versus Conservative Treatment in Heart Transplant Patients for a Clinical Event Reduction: THE ARCHER TRIAL
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25%
研究概览
简要总结
The aim of the study is to compare optimal medical therapy alone versus percutaneous coronary intervention on top of medical therapy in the setting of heart transplant recipient coronary artery disease in a randomized trial.The primary endpoint assessed at 1 year is the composite of death, myocardial infarction, need for transitory or permanent ventricular assist device implantation, myocardial revascularization, occurrence or worsening of heart failure, any graft dysfunction and/or a decrease of left ventricular ejection fraction of at least 25% compared to baseline. The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study.
详细描述
The hypothesis of the study is the superiority of the interventional management over medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after randomization.
Objectives: To demonstrate the superiority of the interventional management on top of optimal medical therapy over optimal medical therapy alone in preventing the occurrence of the primary endpoint of the study assessed 1 year after randomization
Design : Multicenter, prospective randomized 1 :1, open-label blinded endpoint study
Target population : Heart transplant recipients, aged ≥18 years, without coronary artery disease-related symptoms, with angiographically significant coronary artery stenoses (≥50% anatomically adequate for a revascularization by coronary angioplasty with stent implantation, with no contraindication to dual antiplatelet therapy associating aspirin and a P2Y12 inhibitorfor a duration of 12 monthsand with ni grade IA ACC/AHA indication for revascularization
Inclusion period: 12 months (may be extended based on the inclusion rythme)
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years old
- •Heart transplant recipient
- •Stable clinical situation
- •One or several non-critical coronary stenoses (≥ 50% et ≤ 75% visually or QCA-assessed diameter stenosis) considered as adequate for coronary stenting by the operator
- •Left ventricular ejection fraction ≥ 40%
- •Informed consentement signed by the patient
排除标准
- •Acute coronary syndrome
- •In-stent restenosis
- •Proof of an extensive myocardial ischemia (≥ 7/17 segments ASE model)
- •Coronary stenosis considered as critical by the operators with slow flow
- •ACC/AHA Class IA indication for revascularization :
- •vessel disease with left ventricular dysfunction
- •Left main stenosis
- •Severe proximal LAD stenosis
- •Contra-indication to dual antiplatelet therapy
- •Decompensated heart failure at the time of randomization
- •Pregnant or breast-feeding women- Patients participating to another clinical research within 30 days before randomization- life expectancy < 1 y
- •Patients unable to observe strict medical therapy and follow-up within 1 year after randomization
研究组 & 干预措施
1: Coronary stent+optimal medical therapy
Coronary stent on top of optimal medical therapy
干预措施: Stent (Device)
1: Coronary stent+optimal medical therapy
Coronary stent on top of optimal medical therapy
干预措施: optimal medical therapy (Drug)
2: Optimal medical therapy
Optimal medical therapy
干预措施: optimal medical therapy (Drug)
结局指标
主要结局
The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25%
时间窗: at 1 year
The composit of death, myocardial infarction, retransplantation, implantation of transitory or definitive ventricular assist devices, new or worsening heart failure, graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year
次要结局
- Death at 1 year(at 1 year)
- graft failure and/or a decrease of left ventricular ejection fraction of at least 25% at 1 year compared to baseline(at 1 year)
- implantation of transitory or definitive ventricular assist devices at 1 year(at 1 year)
- new or worsening heart failure at 1 year(at 1 year)
- myocardial infarction at 1 year(at 1 year)
- Retransplantation at 1 year(at 1 year)