Introduction: Recent studies have suggested that trimetazidine may help reduce myocardial damage following percutaneous coronary intervention. However, the evaluation of the potential of this medication in the reduction of myocardial damage in patients with diabetes mellitus and unstable angina, in a prospective and randomized way, has not yet been described. Objective: The aim of this study was to evaluate the efficacy and safety of the use of trimetazidine versus placebo in patients with diabetes mellitus and unstable angina undergoing coronary stent angioplasty. Methodology: For this, a unicentric, randomized, double blind and prospective study will be performed in a comparative manner. Hospital data (test results, medical outcomes, drug dose, complications) of patients will be analyzed for safety and effectiveness. Myocardial damage will be measured by means of ultrasensitive Troponin dosages. Expected results: The use of trimetazidine reduces myocardial damage in patients with diabetes mellitus and unstable angina undergoing coronary stent angioplasty.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
120
Pills of masking drug - trimetazidine
Pills of masking drug - placebo
Instituto do Coração - HMFMUSP
São Paulo, Brazil
RECRUITINGpeak values of troponin and CKMB after PCI
comparing groups for peak values of troponin and CKMB after PCI.
Time frame: 24 hours
peak values of CRP
Comparison between groups for peak values of CRP after PCI.
Time frame: 24 hours
peak values of creatinine
Comparison between groups for peak values of creatinine after PCI.
Time frame: 24 hours
peak values of leukogram
Comparison between groups for peak values of leukogram after PCI.
Time frame: 24 hours
occurrence of sustained ventricular arrhythmia
Combined comparison between the occurrence of sustained ventricular arrhythmia
Time frame: 24 hours
occurrence of cardiogenic shock,
Combined comparison between the occurrence of cardiogenic shock,
Time frame: 24 hours
occurrence of cardiorespiratory arrest,
Combined comparison between the occurrence of cardiorespiratory arrest
Time frame: 24 hours
occurrence of worsening of renal function
Combined comparison between the occurrence of worsening of renal function (increase of 0.5 mg / dL in relation to admission creatinine or 25% above baseline)
Time frame: 24 hours
occurrence of need for reintervention
Combined comparison between the occurrence of need for reintervention
Time frame: 24 hours
occurrence of cerebrovascular accident
Combined comparison between the occurrence of cerebrovascular accident
Time frame: 24 hours
occurrence of death
Combined comparison between the occurrence of death
Time frame: 24 hours
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