Discontinuation of β-blocker Therapy in Stabilized Patients After Acute Myocardial Infarction: A Multicenter Randomized Noninferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,540
- 试验地点
- 1
- 主要终点
- Major adverse cardiac events
研究概览
简要总结
The aim of the study is to determine whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without heart failure (HF) or left ventricular systolic dysfunction after acute myocardial infarction (AMI).
Prospective, open-label, randomized, multicenter, noninferiority trial to determine whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without HF or left ventricular systolic dysfunction after AMI.
详细描述
β-blockers have anti-ischemic, anti-arrhythmic, and anti-adrenergic properties. In order to reduce cardiovascular mortality and morbidity, current major guidelines recommend that oral treatment of β-blockers should be continued during and after hospitalization in patients with acute myocardial infarction (AMI) and without contraindications to β-blocker use.
A clinically important but difficult decision on β-blocker therapy after AMI is to determine the duration of β-blocker therapy after discharge in patients without heart failure (HF) or left ventricular systolic dysfunction. Previous studies for long-term β-blocker therapy after AMI were inadequate to derive definite conclusion because of small sample size and potential selection bias.
Therefore, the SMART-DECISION trial will investigate whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without HF or left ventricular systolic dysfunction after AMI.
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
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 19 years of age.
- •Subject who have been continuing β-blocker therapy for at least 1 year after acute myocardial infarction regardless of the time of diagnosis
- •Subject is able to verbally confirm understandings of risks and benefits of this trial, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
排除标准
- •Subject whose left ventricle ejection fraction was less than 40% from echocardiography performed after acute myocardial infarction or who have never received echocardiography.
- •Treatment history of heart failure
- •Contraindication to β-blocker therapy (history of symptomatic bronchial asthma or chronic obstructive pulmonary disease, 2nd or 3rd degree AV block, cardiac pacemaker implantation, or other cases where β-blocker cannot be used under the judgment of the clinician)
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
- •History of atrial fibrillation
- •Pregnancy or breast feeding
研究组 & 干预措施
β-blocker discontinuation arm
Discontinuation of β-blocker therapy after at least 1 year of β-blocker therapy after acute myocardial infarction
干预措施: Discontinuation of β-blocker (Drug)
结局指标
主要结局
Major adverse cardiac events
时间窗: 2.5 years after last patient enrollment
a composite of all-cause death, myocardial infarction, hospitalization for heart failure
次要结局
- Myocardial infarction or any revascularization(2.5 years after last patient enrollment)
- N-terminal pro-brain natriuretic peptide (NT-proBNP)(2.5 years after last patient enrollment)
- Medical cost(at 2 years)
- All-cause death(2.5 years after last patient enrollment)
- Hospitalization for acute coronary syndrome(2.5 years after last patient enrollment)
- Adverse effects related with β-blocker(2.5 years after last patient enrollment)
- Cardiovascular death(2.5 years after last patient enrollment)
- Myocardial infarction(2.5 years after last patient enrollment)
- Cardiovascular death or myocardial infarction(2.5 years after last patient enrollment)
- Myocardial infarction or hospitalization for heart failure(2.5 years after last patient enrollment)
- Any hospitalization(2.5 years after last patient enrollment)
- Hospitalization for heart failure(2.5 years after last patient enrollment)
- All-cause death or myocardial infarction(2.5 years after last patient enrollment)
- Cardiovascular death, myocardial infarction, or any revascularization(2.5 years after last patient enrollment)
- left ventricle ejection fraction(at 2 years)
- Atrial fibrillation occurrence(2.5 years after last patient enrollment)
- Any revascularization(2.5 years after last patient enrollment)
- Cardiovascular death, myocardial infarction, or hospitalization for heart failure(2.5 years after last patient enrollment)
- Rate of Stroke(2.5 years after last patient enrollment)
- PROMIS 29(2.5 years after last patient enrollment)
- Rate of Hospitalization for cardiovascular causes(2.5 years after last patient enrollment)
研究者
Joo-Yong Hahn
MD, PhD, Division of Cardiology, Department of Medicine
Samsung Medical Center