Does Cyclosporine ImpRove Clinical oUtcome in ST Elevation Myocardial Infarction Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 970
- 试验地点
- 44
- 主要终点
- Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]
研究概览
简要总结
Infarct size is a major determinant of prognosis after Acute Myocardial Infarction (AMI). The investigators recently reported that cyclosporine A, when administered immediately prior to percutaneous coronary intervention (PCI), can significantly reduce infarct size in STEMI (ST Elevation acute Myocardial Infarction) patients. The objective of the present study is to determine whether cyclosporine can improve STEMI patient clinical outcome. Nine-hundred and seventy two patients with ST elevation MI will be entered into a multicentre, randomized, placebo-controlled, double-blinded study. They will receive one single injection of cyclosporine A (CicloMulsion, verum) or an equivalent volume of placebo prior to reperfusion therapy by PCI. The incidence of the combined endpoint (mortality, hospitalization for heart failure, left ventricular (LV) remodeling) will be assessed at one year and three years after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Eligibility criteria (for screening before hospital admission):
- •All (male and female) patients, aged over 18, without any legal protection measure,
- •Having a health coverage,
- •Presenting within 12 hours of the onset of chest pain,
- •Who have ST segment elevation ≥0.2 mV in two contiguous leads,
- •For whom the clinical decision was made to treat with percutaneous coronary intervention (PCI).
- •And (further inclusion criteria to be confirmed by the admission coronary-angiography):
- •The culprit coronary artery has to be the LAD
- •The LAD artery has to be occluded (TIMI flow grade 0-1) at the time of admission coronary angiography.
- •Preliminary oral informed consent followed by signed informed consent as soon as possible.
- •Patients undergoing either primary PCI or rescue PCI are eligible for the study. Patients with previous AMI, PCI or coronary artery bypass surgery (CABG) are eligible for the study.
排除标准
- •Patients with loss of consciousness or confused
- •Patients with cardiogenic shock
- •Patients with the left circumflex or the right coronary artery (RCA) as the culprit artery, or with evidence of coronary collaterals to the risk region
- •Patients with an opened (TIMI > 1) LAD coronary artery at admission on initial (admission) coronary angiography
- •Patients with 5.
- •known hypersensitivity to cyclosporine 5.
- •known hypersensitivity to egg, peanut or Soya-bean proteins 5.
- •known renal insufficiency (either known creatinin clearance < 30 ml/min/1.73m² or current medical care for severe renal insufficiency) 5.
- •known liver insufficiency 5.
- •uncontrolled (treated or untreated) hypertension (> 180/110 mmHg)
- •Patients treated with any compound containing Hypericum perforatum (St.-John's-worth) or Stiripentol or Aliskiren or Bosentan or Rosuvastatine
- •Female patients currently pregnant or women of childbearing age who were not using contraception (oral diagnosis).
- •Patients with any disorder associated with immunological dysfunction more recently than 6 months prior to presentation 8.
- •cancer, lymphoma 8.
- •known positive serology for HIV, or hepatitis
研究组 & 干预措施
Cyclosporin
Injection of Cyclosporin A : one single intravenous bolus injection of 2.5 mg/Kg Echocardiography
干预措施: Injection of Cyclosporin (Drug)
Cyclosporin
Injection of Cyclosporin A : one single intravenous bolus injection of 2.5 mg/Kg Echocardiography
干预措施: Echocardiography (Procedure)
Control
one single intravenous bolus injection of Placebo Echocardiography
干预措施: Placebo (Drug)
Control
one single intravenous bolus injection of Placebo Echocardiography
干预措施: Echocardiography (Procedure)
结局指标
主要结局
Combined incidence of [total mortality; hospitalization for heart failure; LV remodeling (increase of LV end-diastolic volume > 15%)]
时间窗: at 1 year post-AMI
次要结局
- Ejection fraction(at 1 year)
- Unstable angina(at 1 year)
- Stroke(at 1 year)
- Infarct size(at 1 year)
- Infarct size: peak Troponin (T or I)(At admission and at 4 hours (+/- 30 minutes) after study treatment administration)
- Left-Ventricular End-Diastolic Volume (LVEDV)(at 1 year)
- Left-Ventricular End-Systolic Volume (LVESV)(at 1 year)
- Total mortality(at 1 year)
- Cardiovascular death(at 1 year)
- Heart failure(at 1 year)
- Myocardial infarction(at 1 year)
- Microvascular obstruction (no reflow)(During hospitalization at admission)