Efficacy and safety of trimetazidine in patients with angina having been treated by dilatation of coronary arteries.

Conditions: Patients with Angina pectoris having been treated by Percutaneous Coronary Intervention
MedDRA version: 16.1Level: PTClassification code 10002383Term: Angina pectorisSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2010-022134-89-LT

Lead Sponsor: I.R.I.S.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10300

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
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

Exclusion Criteria

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Demonstrate the superiority of trimetazidine over placebo in preventin recurrence or exacerbation of angina pectoris and reducing cardiac events, and to document its safety by analysing the occurrence of serious adverse events;Secondary Objective: Evaluate the effect of trimetazidine on the other efficacy endpoints as well as the other safety parameters, clinical and biological;Timepoint(s) of evaluation of this end point: all over the study;Primary end point(s): Time to first occurrence of an event in the composite of:<br>- Cardiac death<br>- Hospitalisation for a cardiac event<br>- Recurrent or persistent angina leading to adding, switching or increasing the dose of one of the evidence-based antianginal therapies<br>- Recurrent or persistent angina leading to performing a coronary angiography

Secondary Outcome Measures