BEtablocker Treatment After Acute Myocardial Infarction in Patients Without Reduced Left Ventricular Systolic Function (BETAMI)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,895
- 试验地点
- 20
- 主要终点
- A composite of death of any cause, recurrent myocardial infarction, incident heart failure, coronary revascularization, ischemic stroke, malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin
研究概览
简要总结
The study aims to investigate whether oral betablocker (BB) therapy is superior to no such treatment following an acute myocardial infarction (AMI).
详细描述
This is a prospective, randomized, open blinded end-point (PROBE) study. Patients with AMI will be randomized 1-8 days following PCI or thrombolysis, and allocated to either prescription of a BB or to no such prescription. Subjects will be followed up for at least 6 months (median 3 years) with respect to the primary and secondary endpoints. The primary end point, the key secondary end points, and most other secondary end points will be analysed and published jointly with data from the 'Danish Trial of Beta-blocker therapy after myocardial infarction without heart failure' (DANBLOCK) (NCT 03778554) (please see below).
The primary objective is to test whether oral BB therapy reduces the risk of all-cause death, recurrent MI, incident heart failure, unplanned coronary revascularization, ischemic stroke, or malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin compared to no such therapy, in patients with AMI treated with PCI or thrombolysis without reduced LVEF.
The key secondary objectives (planned for the main study) are:
- To study whether oral BB therapy reduces the risk of each of the components of the primary end-point separately, compared to no such therapy
- To assess clinical outcomes linked BB therapy in the following subgroups: age (tertiles< 70 years vs. ≥70 years), gender sex (men vs. women), country (Denmark vs Norway), BB dosage tertiles (dosage at randomization (<50 mg vs. ≥50 mg), hypertension (yes vs. no), diabetes (yes vs. no), diabetes (yes vs no), type of MI (STEMI vs. NSTEMI), and LVEF subgroups (preserved LVEF: ≥50% vs. mid-range LVEF: 40-49%).
- To study whether oral BB therapy increases the risk of hospitalization for second or third-degree atrioventricular block or implantation of pacemaker.
- To describe BB dosage and adherence at six months following randomization obtained from the national prescription registries
- To assess study safety
Other secondary objectives (for joint BETAMI-DANBLOCK sub-studies) are:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Betablocker
Patients receiving a betablocker. Any other treatment or management is to be given as per usual care.
干预措施: Betablocker (Drug)
Non-Betablocker
No betablocker is given to this arm. Any other treatment or management is to be given as per usual care.
干预措施: Non-betablocker (Other)
结局指标
主要结局
A composite of death of any cause, recurrent myocardial infarction, incident heart failure, coronary revascularization, ischemic stroke, malignant ventricular arrhythmia including resuscitated cardiac arrest of cardiac origin
时间窗: 6 months (minimum) to 6 years (maximum)
Incidence of combined endpoint from randomization. Estimated maximal follow-up for each patient for this outcome is 6 months to 6 years
次要结局
- Recurrent MI(6 months (minimum) to 6 years (maximum))
- All-cause death(6 months (minimum) to 6 years (maximum))
- Hospitalization or outpatient consultation for incident heart failure(6 months (minimum) to 6 years (maximum))
- Malignant ventricular arrhythmias including resuscitated cardiac arrest of cardiac origin(6 months (minimum) to 6 years (maximum))
- Hospitalization for bradycardia, syncope or implantation of pacemaker(6 months (minimum) to 6 years (maximum))
- Unplanned coronary revascularization(6 months (minimum) to 6 years (maximum))
- Measures of Nightmare Frequency(Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months)
- Ischemic stroke(6 months (minimum) to 6 years (maximum))
- Cardiovascular death(6 months (minimum) to 6 years (maximum))
- Hospitalization for stable and unstable angina(6 months (minimum) to 6 years (maximum))
- Hospitalization for chronic obstructive pulmonary disease, asthma or peripheral artery disease(6 months (minimum) to 6 years (maximum))
- Hospitalization for atrial fibrillation, atrial flutter or other atrial tachyarrhythmias(6 months (minimum) to 6 years (maximum))
- Angina symptoms(Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months)
- Health-related quality of life(Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months)
- Measures of sleep disorders(Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months)
- Measures of depression and anxiety(Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months)
- Measures of sexual dysfunction(Through self-report questionnaires administered at inclusion, 30 days, 3,6 and 18 months)
研究者
Dan Atar
Professor of Cardiology
Oslo University Hospital