Trimetazidine in Myocardial Injury After Percutaneous Coronary Intervention in Patients With Angina and Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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PROSPECTIVE ANALYSIS BETWEEN TRIMETAZIDINE Versus PLACEBO IN MYOCARDIAL INJURY AFTER PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS WITH INSTANT ANGINA AND DIABETES MELLITUS

Conditions
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Diabetes Mellitus, Angina, Unstable

Intervention / Treatment
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* Drug: trimetazidine
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult men and women aged> 18 years. Diagnosis of unstable angina with chest pain at least 2 hours after arrival at the emergency unit. Measurement of troponin less than the upper limit of the normality of the method. Indication of cardiac catheterization and need for percutaneous coronary intervention with uniarterial stent within 24 hours of admission. No known allergy to trimetazidine. Prior diagnosis of diabetes mellitus under specific treatment. ClCr> 30 mL / min. Signed consent form. Exclusion Criteria: Pregnancy. Hemodynamic instability (pulmonary congestion / systolic blood pressure less than 90 mmHg). SCA with ST elevation or troponin elevation. Body mass index greater than 40 kg / m2. Use of oral anticoagulant. Orotracheal intubation. Left ventricular outflow tract obstruction. Allergy to iodinated contrast. Thoracic trauma in the last 30 days. Previous surgical myocardial revascularization. Presence of ventricular arrhythmias.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trimetazidine<br>The randomization will be done with a list generated by the central pharmacy of the Hospital das Clínicas, Medical School, USP. When the patient is randomized to the trimetazidine pill group, he / she will initiate the medication at 70 mg oral dose (2 tablets of Vastarel ® MR 35 mg single dose) 2 hours before the procedure. | Drug: trimetazidine<br>* Pills of masking drug - trimetazidine<br>|
| Experimental: placebo<br>The randomization will be done with a list generated by the central pharmacy of the Hospital das Clínicas, Medical School, USP. When randomized to the placebo oral tablets group, the patient will receive placebo (orally, 2 single dose tablets) also 2 hours prior to PCI. | Drug: Placebo Oral Tablet<br>* Pills of masking drug - placebo<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak values of troponin and CKMB after PCI | comparing groups for peak values of troponin and CKMB after PCI. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peak values of CRP | Comparison between groups for peak values of CRP after PCI. | 24 hours | 
| peak values of creatinine | Comparison between groups for peak values of creatinine after PCI. | 24 hours | 
| peak values of leukogram | Comparison between groups for peak values of leukogram after PCI. | 24 hours | 
| occurrence of sustained ventricular arrhythmia | Combined comparison between the occurrence of sustained ventricular arrhythmia | 24 hours | 
| occurrence of cardiogenic shock, | Combined comparison between the occurrence of cardiogenic shock, | 24 hours | 
| occurrence of cardiorespiratory arrest, | Combined comparison between the occurrence of cardiorespiratory arrest | 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) | 24 hours | 
| occurrence of need for reintervention | Combined comparison between the occurrence of need for reintervention | 24 hours | 
| occurrence of cerebrovascular accident | Combined comparison between the occurrence of cerebrovascular accident | 24 hours | 
| occurrence of death | Combined comparison between the occurrence of death | 24 hours |