The efficAcy and safety of Trimetazidine in Patients withangina pectoris having been treated by percutaneous CoronaryIntervention. ATPCI studyAn international, multicentre, randomised, double-blind, placebo-controlled study in patients treated for 2 to 4 years.

I.R.I.S.0 个研究点目标入组 10,300 人开始时间: 2013年10月14日最近更新: 2014年4月7日

试验速览

暂无简介。

•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 5900
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 4400

•- Severe uncontrolled rythm disturbances including paroxysmal VT and SVT
•- Kown 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

发起方

I.R.I.S.