跳至主要内容
临床试验/NL-OMON38975
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

Servier0 个研究点目标入组 200 人开始时间: 待定最近更新:
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

发起方
Servier

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