A Double-blind, Randomized, Placebo-controlled Trial Evaluating The Safety And Efficacy Of Early Treatment With Eplerenone In Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,012
- 试验地点
- 74
- 主要终点
- First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off
研究概览
简要总结
Administration of eplerenone within 24 hours of onset of symptoms of myocardial infarction, in patients without heart failure, reduces cardiovascular mortality / morbidity.
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
- •Subjects must have experienced a myocardial infarction (STEMI) within the previous 24 hours confirmed by symptoms and ECG.
排除标准
- •Subjects with a known low ejection fraction of less than 40% or any previous history of heart failure.
- •Subjects treated with eplerenone or other aldosterone antagonists within the past 1 month.
- •The subject has uncontrolled hypotension (SBP<90mmHg).
- •Subjects with eGFR ≤30ml/min (based on admission serum creatinine and the MDRD formula) or serum creatinine ≥220µmol/L.
研究组 & 干预措施
Placebo plus standard of care
Matching placebo for eplerenone 25mg film coated tablets.
干预措施: Placebo (Drug)
Eplerenone plus standard of care
干预措施: Eplerenone (Drug)
结局指标
主要结局
First Event of Cardiovascular Mortality, Re-hospitalization or Extended Initial Hospital Stay Due to Diagnosis of Heart Failure, Sustained Ventricular Tachycardia or Fibrillation, Ejection Fraction ≤40% or BNP Above Age Adjusted Cut Off
时间窗: 0-24 months
Cardiovascular mortality is defined as any mortality adjudicated as death due to sudden cardiac death, myocardial infarction (MI), worsening heart failure, cardiac arrhythmia, other cause (such as pulmonary embolism, peripheral arterial disease \[PAD\], etc.). Hospitalization due to congestive heart failure (CHF) and requires extended hospital stay or frequent visits to emergency room, observation unit or in-patient care, due to CHF as the primary or secondary diagnosis supported by a discharge report or clinical summary for hospitalization as determined by the endpoint adjudication committee (EAC). A composite of time to first event of cardiovascular mortality (CV), re-hospitalization or extended initial hospital stay due to diagnosis of heart failure, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40% after 1 month or BNP \>200 pg/mL or NT-proBNP \>450 pg/mL (age \<50 years); \>900 pg/mL (age 50 to 75 years) or \>1800 pg/mL (age \>75 years) after 1 month.
次要结局
- Diagnosis of Heart Failure(0-24 months)
- Brain (B-type) Natriuretic Peptide (BNP) >200 pg/mL or NT-proBNP >450, >900 or >1800 pg/mL for Ages <50 Years, 50-75 Years and >75 Years, Respectively (Recorded 1 Month or Later Post-randomization).(0-24 months)
- Electrocardiogram Q Wave to the End of the S Wave Corresponding to Ventricle Depolarization (QRS) Duration at 6 Months Post-randomization.(6 months)
- Cardiovascular Mortality(0-24 months)
- Change in Serum Levels of Biomarkers (PIIINP, Galectin 3, and PINP) at 6 Months Post-randomization.(6 months)
- First and Each Subsequent Episode (After an Event Free Interval of ≥ 48 Hours) of Sustained Ventricular Tachycardia or Ventricular Fibrillation.(0-24 months)
- First Recorded Ejection Fraction (EF) of ≤40% (Recorded 1 Month or Later Post-randomization).(0-24 months)
- Change in Serum Level of Biomarker (Interleukin-6) at 6 Months Post-randomization.(6 months)
- Decision to Provide an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT).(0-24 months)
- Second or Subsequent Non-fatal Myocardial Infarction (MI).(0-24 months)
- Left Atrial Diameter (LAD) (Recorded on Each Occasion an Echocardiogram is Conducted).(0-24 months)
- Change in Serum Levels of Biomarkers (Aldosterone and Cortisol) at 6 Months Post-randomization.(6 months)
- Change in Serum Level of Biomarker (ICTP) at 6 Months Post-randomization.(6 months)