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.
- Conditions
- spasm of the heart10011082chest pain
- Registration Number
- NL-OMON38975
- Lead Sponsor
- Servier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 200
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
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Superiority of trimetazidine over placebo on the time to first occurrence of an<br /><br>event in the composite of:<br /><br>- cardiac death;<br /><br>- hospitalisation for a cardiac event;<br /><br>- Recurrent or persistent angina leading to adding, switching or increasing the<br /><br>dose of one of the evidence-based antianginal therapies;<br /><br>- recurrent or persistent angina leading to performing a coronary angiography.</p><br>
- Secondary Outcome Measures
Name Time Method