Angina, Unstable, Diabetes Mellitus
Conditions
Brief summary
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.
Interventions
DRUGtrimetazidine
Pills of masking drug - trimetazidine
DRUGPlacebo Oral Tablet
Pills of masking drug - placebo
Sponsors
University of Sao Paulo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| peak values of troponin and CKMB after PCI | 24 hours | comparing groups for peak values of troponin and CKMB after PCI. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| peak values of creatinine | 24 hours | Comparison between groups for peak values of creatinine after PCI. |
| peak values of leukogram | 24 hours | Comparison between groups for peak values of leukogram after PCI. |
| occurrence of sustained ventricular arrhythmia | 24 hours | Combined comparison between the occurrence of sustained ventricular arrhythmia |
| occurrence of cardiogenic shock, | 24 hours | Combined comparison between the occurrence of cardiogenic shock, |
| peak values of CRP | 24 hours | Comparison between groups for peak values of CRP after PCI. |
| occurrence of worsening of renal function | 24 hours | 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) |
| occurrence of need for reintervention | 24 hours | Combined comparison between the occurrence of need for reintervention |
| occurrence of cerebrovascular accident | 24 hours | Combined comparison between the occurrence of cerebrovascular accident |
| occurrence of death | 24 hours | Combined comparison between the occurrence of death |
| occurrence of cardiorespiratory arrest, | 24 hours | Combined comparison between the occurrence of cardiorespiratory arrest |
Countries
Brazil
Contacts
Primary ContactAlexandre Soeiro, MD
Outcome results
None listed