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-DK
• Lead Sponsor: I.R.I.S.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-23
• Last Update Posted: 2 June 2014

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