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 InterventionMedDRA version: 16.0 Level: PT Classification code 10002383 Term: Angina pectoris System Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2010-022134-89-ES
- Lead Sponsor
- I.R.I.S.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 10300
Women or men greater than or equal 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
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;<br> 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<br> ;Timepoint(s) of evaluation of this end point: all over the study
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary efficacy endpoints and safety;Timepoint(s) of evaluation of this end point: All over the study