Randomized Evaluation of Decreased Usage of betablocCkErs After Myocardial Infarction in the SWEDEHEART Registry - A Registry-based, Randomized, Parallel, Open-label, Multicenter Trial (REDUCE-SWEDEHEART)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Time to the composite of death of any cause or MI
研究概览
简要总结
Long-term beta-blocker therapy has not been investigated in contemporary randomized clinical trials in patients with myocardial infarction and normal heart function. The aim of this study is to determine whether long-term treatment with oral beta-blockade in patients with myocardial infarction and preserved left ventricular systolic ejection fraction reduces the composite of death of any cause or new myocardial infarction..
详细描述
REDUCE-SWEDEHEART is designed as a registry-based, randomized, parallel, open-label, multicenter trial.
Patients, day 1-7 after myocardial infarction, who have undergone a coronary angiography and with preserved left ventricular systolic ejection fraction will be randomized to either oral beta-blockade (see "Intervention" for detailed description) at a dose according to the treating physician, or no beta-blockade. To allow quick inclusion the randomization module will be accessible by a simple web-based log-in procedure. Concomitantly, all baseline data about each individual patient will be collected from the SWEDEHEART registry. Patients will then be followed regarding all-cause mortality, myocardial infarction, heart failure, atrial fibrillation, and patient-related outcome measures (for a subgroup of patients). Patients that are eligible but not included in REDUCE-SWEDEHEART will also be followed regarding chosen treatment and the primary and secondary endpoints.
Follow-up will continue until 379 primary endpoints have been observed (endpoint driven). All analyses will be performed on the intention-to-treat set, defined as all intentionally randomized patients, by randomized treatment. The primary endpoint is death or new MI. Information about death will be obtained from the Swedish population registry. Information regarding new myocardial infarction during hospitalization and readmission because of myocardial infarction or other outcome (secondary outcomes, see section below), will be obtained from the SWEDEHEART-registry (for myocardial infarction) and the patient registry of the National board of health and welfare.
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
- •Age≥18 years.
- •Day 1-7 after MI as defined by the universal definition of MI, type 1, included in the SWEDEHEART registry.
- •Undergone coronary angiography during hospitalization.
- •Obstructive coronary artery disease documented by coronary angiography, i.e. stenosis ≥ 50 %, FFR ≤ 0.80 or iFR ≤ 0.89 in any segment at any time point before randomization.
- •Echocardiography performed after the MI showing a normal ejection fraction (EF≥50%).
- •Written informed consent obtained.
排除标准
- •Any condition that may influence the patient's ability to comply with study protocol.
- •Contraindications for beta-blockade
- •Indication for beta-blockade other than as secondary prevention according to the treating physician.
研究组 & 干预措施
Oral beta-blocker treatment
Patients randomized to beta-blockade will be prescribed oral beta-blocker (metoprolol succinate or bisoprolol) at a dose according to the treating physician. Metoprolol succinate will be strongly recommended as first choice. Bisoprolol will be allowed as an alternative. Atenolol (or any other beta-blocker therapy) will not be allowed. The treating physician will be encouraged to aim for a dose of ≥ 100 mg for metoprolol succinate and ≥ 5 mg for bisoprolol. Prescribed treatment and dosing will be registered. Initiation (whether the prescribed drug is dispensed) and adherence (defined as proportion of prescribed tablets that are dispensed), and persistence (time on treatment) will also be recorded via the Drug prescription registry.
干预措施: Metoprolol Succinate (Drug)
Oral beta-blocker treatment
Patients randomized to beta-blockade will be prescribed oral beta-blocker (metoprolol succinate or bisoprolol) at a dose according to the treating physician. Metoprolol succinate will be strongly recommended as first choice. Bisoprolol will be allowed as an alternative. Atenolol (or any other beta-blocker therapy) will not be allowed. The treating physician will be encouraged to aim for a dose of ≥ 100 mg for metoprolol succinate and ≥ 5 mg for bisoprolol. Prescribed treatment and dosing will be registered. Initiation (whether the prescribed drug is dispensed) and adherence (defined as proportion of prescribed tablets that are dispensed), and persistence (time on treatment) will also be recorded via the Drug prescription registry.
干预措施: Bisoprolol (Drug)
结局指标
主要结局
Time to the composite of death of any cause or MI
时间窗: through study completion, an average of 3 year
Time to the composite of death of any cause or MI on an intention to treat basis (ITT)
次要结局
- Stroke(through study completion, an average of 3 year)
- Asthma or Chronic Obstructive Pulmonary Disease(through study completion, an average of 3 year)
- Health related quality of life (HRQOL)(Estimated maximal follow-up for each patient for this outcome is 1 year.)
- Health care costs(through study completion, an average of 3 year)
- All-cause death(through study completion, an average of 3 year)
- Myocardial infarction(through study completion, an average of 3 year)
- Heart failure(through study completion, an average of 3 year)
- Bradycardia, Advanced AV-block, hypotension, syncope or need for pacemaker(through study completion, an average of 3 year)
- Cardiovascular death(through study completion, an average of 3 year)
- Atrial fibrillation(through study completion, an average of 3 year)
研究者
Dr. Tomas Jernberg
Co-ordinating principal investigator
Karolinska Institutet