NL-OMON38975撤回3 期
The efficAcy and safety of Trimetazidine in Patients with angina pectoris having been treated by percutaneous Coronary Intervention. ATPCI study An international, multicentre, randomised, double-blind, placebo-controlled study in patients treated for 2 to 4 years. - ATPCI study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Servier
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •Women or men >= 21 years old and < 85 years old of any ethnic origin.
- •Patients presenting a single or multivessel coronary artery disease and having undergone PCI treating at least one stenosis to either a native coronary artery or a coronary graft where the PCI was:
- •- indicated because of angina pectoris occurring either in the context of stable angina (elective PCI) or in the context of an acute presentation such as unstable angina/NSTEMI, but excluding STEMI;
- •- achieved by stent implantation or by other acceptable interventional means;
- •- successful as planned by the operator and with no further revascularization (either percutaneous or surgical) planned;
- •- uncomplicated such that the patient's discharge was not, or will not be, delayed because of a cardiac or cerebrovascular problem
排除标准
- •- Severe uncontrolled rythm disturbances including paroxysmal VT and SVT;- Known severe aortic or mitral valve disease;
- •- Clinical signs and/or symptoms of heart failure corresponding to NYHA class IV;
- •- Hypertrophic obstructive cardiomyopathy or other forms of left ventricular outflow tract obstruction;
- •- Active myocarditis, pericarditis or endocarditis;
- •- Hystory of agranulocytosis, severe thrombocytopenia or severe coagulation disorder;
- •- History of pulmonary embolism within preceding 6 months;
- •- Known severe uncontrolled arterial hypertension;
- •- Known chronic severe or moderate renal failure, with sCrCl < 60 mL/min or eGFR<60 mL/min/1.73m²;
- •- Current or previous movement disorders such as Parkinsonian symptoms, restless leg syndrome, tremor, gait instability of central origin
研究者
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