The Study to Assess the Effect of Trimetazidine on Index of Microcirculatory Resistance (IMR), Measured by Coronary Pressure and Temperature Wire, in Patients With Stable Coronary Artery Disease

ZEM - CARD - 002

The study should enrol 50 patients with stable coronary artery disease scheduled for elective percutaneous coronary intervention of single, de novo lesion of native coronary artery. Patients will be randomized to orally given trimetazidine on top of standard medical therapy for stable coronary artery disease versus standard therapy only. The randomization will begin 48 hrs before intervention. Index of microcirculatory resistance (IMR) will be measured by thermodilution method using coronary pressure and temperature wire before and after stent implantation. Echocardiography will be performed before intervention and within 30 minutes after intervention. Patients will be followed clinically for a period of one year.

2014-04-01

2023-03-01

2023-03-01

Completed

Early phase I

71

Inclusion Criteria: * presence of the stable angina or positive stress test * Canadian Cardiovascular Society (CCS) class less than IV * single, de novo, native coronary artery lesion * diameter stenosis greater than 70%. Exclusion Criteria: * left ventricular systolic function (LVEF) less than 30% * acute coronary syndrome * history of previous myocardial infarction in the territory supplied by the treated coronary artery * existence of the collateral circulation to another coronary artery supplied by the treated vessel * chronic total occlusion * significant bifurcation lesion * previous surgical revascularization * significant renal function impairment (GFR less than 60ml/min) allergy to any constituents of trimetazidin, aspirin and antiplatelet medications used after PCI, contrast agents * contraindication to adenosine use * Parkinson disease * parkinsonian symptoms, tremors, restless leg syndrome, and other related movement disorders

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 71, 'type': 'ACTUAL'}}

2023-06-02