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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| trimetazidine | Experimental | The randomization will be done with a list generated by the central pharmacy of the Hospital das ClÃnicas, 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. |
|
| placebo | Experimental | The randomization will be done with a list generated by the central pharmacy of the Hospital das ClÃnicas, 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| trimetazidine | Drug | Pills of masking drug - trimetazidine |
| |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandre Soeiro, MD | Contact | +55112661-5299 | alexandre.soeiro@bol.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Mucio Tavares, MD | Unidade ClÃnica de Emergência | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Instituto do Coração - HMFMUSP | Recruiting | São Paulo | 05403000 | Brazil |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D000789 | Angina, Unstable |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D014292 | Trimetazidine |
| ID | Term |
|---|---|
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo Oral Tablet |
| Drug |
Pills of masking drug - placebo |
|
|
| 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 |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |