Pharmacologic Prophylaxis for Atrial Fibrillation Following Coronary By-Pass Surgery
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- atrial fibrillation
研究概览
简要总结
The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone and statine is better than beta-blocker alone for the prevention of atrial fibrillation after coronary by-pass surgery.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •significant coronary disease, sinus rhythm
排除标准
- •valvular disease, former by-pass surgery
研究组 & 干预措施
beta blocker and amiodarone
The inteventin will be that patients will receive beta blocker Bisoprolol in adjusted dose + Amiodarone per os starting 7 days before coronary by-pass surgery, 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge
干预措施: Amiodarone tab 200 mg x 3 (Drug)
beta blocker and amiodarone
The inteventin will be that patients will receive beta blocker Bisoprolol in adjusted dose + Amiodarone per os starting 7 days before coronary by-pass surgery, 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge
干预措施: beta blockers Bisoprolol in adjusted dose (Drug)
beta blocker and statin
The intervention will be that patients will receive beta blocker (Bisoprolol tab in adjusted dose)+ Rosuvastatin 20 mg. x 1 starting 7 days before coronary by-pass surgry untill discharge.
干预措施: rosuvastatin 20 mg tab x1 (Drug)
beta blocker and statin
The intervention will be that patients will receive beta blocker (Bisoprolol tab in adjusted dose)+ Rosuvastatin 20 mg. x 1 starting 7 days before coronary by-pass surgry untill discharge.
干预措施: beta blockers Bisoprolol in adjusted dose (Drug)
beta blocker
Patients will receive beta blocker (Bisoprolol tab in adjusted dose).
干预措施: beta blockers Bisoprolol in adjusted dose (Drug)
结局指标
主要结局
atrial fibrillation
时间窗: 10 days on average during hospital stay after coronary by-pass surgery
outcome will be number of patients free from atrial fibrillation.
次要结局
未报告次要终点
研究者
Enes Osmanović
Mr.med.sc.Dr Enes Osmanovic
Heart Center BH Tuzla