PER-084-13已完成未知
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.
Institut de Recherches Internationales Servier I.R.I.S.,0 个研究点目标入组 130 人开始时间: 2014年2月17日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 130
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
- 21 至 85（—）
入选标准
- •Selection/Inclusion criteria
- •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.
- •A measurement of Left Ventricular Ejection Fraction (LVEF) should have been performed within 3 months before inclusion for patients having undergone elective index PCI and between PCI and inclusion for patients having undergone index PCI performed in the context of an acute coronary syndrome. Otherwise, an estimate of the LVEF should be provided.
- •Patients can be selected post PCI regardless of whether they are asymptomatic or symptomatic with regards to angina, and regardless of their CCS class.
排除标准
- •Non selection/Exclusion criteria
- •-General criteria: unlikely to co-operate with study procedures or visits; unlikely to comply with treatment; legal incapacity; pregnancy, breastfeeding or possibility of becoming pregnant during the study; current participation in another randomised study or inclusion in another randomised study within the preceding month; participant already enrolled in the study.
- •-Criteria related to the coronary artery disease: index PCI carried out in the absence of prior chest pain considered to be angina pectoris, including where carried out for asymptomatic ischaemia; index PCI carried out as part of management of STEMI or within 4 weeks following a STEMI; procedure-related Q-wave MI; further revascularization planned during the study period.
- •-Criteria related to clinical events between PCI and Inclusion: occurrence of an event which may prevent the patient to continue in the study correctly; acute myocardial infarction; repeat coronary revascularization; hospitalisation (or prolongation of hospitalisation) for cardiovascular event.
- •Criteria related to concomitant diseases: severe uncontrolled rhythm disturbances; known severe aortic or mitral valve disease; NYHA class IV heart failure; hypertrophic obstructive cardiomyopathy or other forms of left ventricular outflow tract obstruction; congenital heart disease; history of pulmonary embolism within preceding 6 months; active myocarditis, pericarditis or endocarditis; history of thoracic aortic dissection; history of aortic aneurysm; severe uncontrolled arterial hypertension; known unpaced 2nd or 3rd degree atrioventricular block (except Mobitz type I AV block); known current anaemia; current severe hematologic disease; Known chronic severe or moderate renal failure, with eCrCl < 60 mL/min or eGFR <
- •60 mL/min/1.73m²; any state of severe physical or mental illness which may prevent compliance with study procedures or where the patient’s life expectancy is < 5 years; current or previous movement disorders such as Parkinsonian symptoms, restless leg syndrome, tremor, gait instability of central origin; severely reduced mobility.
- •-Criteria related to medication: hypersensitivity to trimetazidine or any of the product’s or placebo’s constituents; ongoing treatment by trimetazidine, perhexiline or ranolazine that cannot be discontinued at the time of inclusion.
- •-Laboratory criteria at inclusion: no available measurement of renal function; eCrCl < 60 mL/min or eGFR < 60 mL/min/1.73m²; haemoglobin <100g/L; AST or ALT > 3-fold above the upper normal values; positive pregnancy test.
- •-ECG criteria at inclusion: unpaced 2nd or 3rd degree AV block except Mobitz Type I AV block.
- •During the study patients should receive a standard post PCI regimen with regards to secondary prevention and regular antianginal therapies, in accordance with local or regional guidelines.
研究者
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