Randomized Evaluation of Beta Blocker and Angiotensin Converting Enzyme Inhibitor (ACEI) /Angiotensin Receptor Blocker (ARB) Treatment in MINOCA Patients.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 198
- 试验地点
- 32
- 主要终点
- Time to death of any cause, or time to readmission because of AMI, ischemic stroke or heart failure
研究概览
简要总结
Myocardial infarction with non-obstructive coronary arteries" (MINOCA) occurs in 5-10% of all patients with AMI. There are neither any randomized clinical trials in MINOCA patients evaluating effects of secondary preventive treatments proven beneficial in patients with classic AMI, nor any treatment guidelines.
The primary objective of this multi-national, multi-center pragmatic randomized clinical trial is to determine whether oral beta-blockade compared to no oral beta-blockade, and whether Angiotensin Converting Enzyme Inhibitors (ACEI/ Angiotensin Receptor Blockers (ARB) compared to no ACEI/ARB, reduce the composite endpoint of death of any cause and readmission because of AMI, ischemic stroke or heart failure in patients discharged with myocardial infarction with non-obstructive coronary artery disease (MINOCA) and with no clinical signs of heart failure and with left ventricular (LV) systolic ejection fraction ≥40%.
详细描述
Large-scale use of acute coronary angiography has revealed a large portion of AMI without angiographically obstructive (defined as ≥50% diameter stenosis) coronary artery disease (CAD). The term "myocardial infarction with non-obstructive coronary arteries" (MINOCA) has been coined for this entity. MINOCA occurs in 5-10% of all patients with AMI and these patients are younger and more often females compared to patients with AMI and obstructive CAD. The 1-year mortality after MINOCA was found to be 3.5% in the systematic review by Pasupathy et al.. There are no randomized clinical trials in MINOCA patients evaluating effects of secondary preventive treatments proven beneficial in patients with classic AMI. However, in an observational study with propensity score matched comparisons the risk of experiencing a Major Adverse Cardiac Event (MACE) was 18% lower in patients treated with ACEI/ARB compared to no ACEI/ARB; in patients on beta blockers compared to patients not using beta blockers there was a non-significant 14% reduction in MACE.
The primary objective of this multi-national, multi-center pragmatic randomized clinical trial is to determine whether oral beta-blockade compared to no oral beta-blockade, and whether ACEI/ARB compared to no ACEI/ARB, reduce the composite endpoint of death of any cause and readmission because of AMI, ischemic stroke or heart failure in patients discharged with myocardial infarction with non-obstructive coronary artery disease (MINOCA) and with no clinical signs of heart failure and with LV systolic ejection fraction ≥40%.
PRIMARY ENDPOINT: Time to death of any cause or readmission because of myocardial infarction, ischemic stroke or heart failure.
SECONDARY ENDPOINTS:
Time to:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- None
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
- •Age >18 years.
- •A clinical diagnosis of MINOCA within the last 30 days.
- •Left ventricular ejection fraction ≥40% measured with echocardiography, MRI or left ventriculography after admission and prior to randomization.
- •Written informed consent obtained
排除标准
- •Any condition that may influence the patient's ability to comply with study protocol.
- •Previous revascularization (CABG or PCI)
- •Clinical signs of heart failure
- •MRI-proven myocarditis or a strong clinical suspicion of myocarditis or takotsubo as cause of the index event
- •Contraindications for Beta blocker treatment
- •Contraindications for ACEI and ARB treatment
- •Prior use of ACEI, ARB, or Beta blockers, which must continue according to treating physician.
- •New indication for Beta blocker or ACEI/ARB treatment other than as secondary prevention according to treating physician
- •Ongoing pregnancy or woman of childbearing potential not using adequate contraceptives
- •Participation in a trial evaluating a drug known to interact with Beta blockers or ACEI/ARB
研究组 & 干预措施
Beta blocker and ACEI/ARB
Beta blocker and either ACE inhibitor or Angiotensin receptor blocker
干预措施: Beta blocker (Drug)
Beta blocker and ACEI/ARB
Beta blocker and either ACE inhibitor or Angiotensin receptor blocker
干预措施: ACEI (Drug)
Beta blocker and ACEI/ARB
Beta blocker and either ACE inhibitor or Angiotensin receptor blocker
干预措施: ARB (Drug)
Beta blocker alone
Beta blocker alone
干预措施: Beta blocker (Drug)
ACEI/ARB alone
Either ACE inhibitor or Angiotensin receptor blocker alone
干预措施: ACEI (Drug)
ACEI/ARB alone
Either ACE inhibitor or Angiotensin receptor blocker alone
干预措施: ARB (Drug)
结局指标
主要结局
Time to death of any cause, or time to readmission because of AMI, ischemic stroke or heart failure
时间窗: Time to event from the date of enrollment through study completion, an average of 4 years.
A Composite of time to all-cause Death and time to re-admission because of AMI, ischemic stroke or heart failure
次要结局
- a All-cause death b Cardiovascular death c Readmission because of AMI d Readmission because of ischemic stroke e Readmission because of heart failure f Readmission because of unstable angina pectoris g Readmission because of atrial fibrillation.(a All-cause death: Time to event from the date of enrollment through study completion, an average of 4 years.)