PROSPECTIVE ANALYSIS BETWEEN TRIMETAZIDINE Versus PLACEBO IN MYOCARDIAL INJURY AFTER PERCUTANEOUS CORONARY INTERVENTION IN PATIENTS WITH INSTANT ANGINA AND DIABETES MELLITUS
试验速览
- 阶段
- 3 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- peak values of troponin and CKMB after PCI
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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 / m
- •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.
研究组 & 干预措施
trimetazidine
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.
干预措施: trimetazidine (Drug)
placebo
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.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
peak values of troponin and CKMB after PCI
时间窗: 24 hours
comparing groups for peak values of troponin and CKMB after PCI.
次要结局
- occurrence of worsening of renal function(24 hours)
- occurrence of cardiorespiratory arrest,(24 hours)
- peak values of CRP(24 hours)
- peak values of creatinine(24 hours)
- peak values of leukogram(24 hours)
- occurrence of sustained ventricular arrhythmia(24 hours)
- occurrence of cardiogenic shock,(24 hours)
- occurrence of need for reintervention(24 hours)
- occurrence of cerebrovascular accident(24 hours)
- occurrence of death(24 hours)