NCT05730413招募中4 期
Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate
研究概览
简要总结
The goal of this interventional clinical trial is compare between two different dose regimens of bisoprolol (beta-blocker) in CABG patients in terms of efficacy and safety.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients: 18 to 65 years old
- •Diagnosed with coronary heart disease or myocardial infarction and scheduled for coronary artery bypass surgery
排除标准
- •History of Ventricular arrhythmia, atrial fibrillation, atrial flutter, left bundle block, AV block grade II/III
- •History of Sick sinus syndrome, sinoatrial heart block
- •History of valve replacement
- •Permanent Pacemaker
- •LVEF less than 30%
- •Unstable Heart failure
- •Cardiogenic shock
- •Sustained systolic blood pressure less than 100 mmHg or HR less than 50 bpm at recruitment
- •Severe chronic obstructive airway disease
- •Severe asthma unless was on previously tolerated bisoprolol dose
- •Uncontrolled diabetes mellitus unless was on previously tolerated bisoprolol dose
- •Pregnant/Lactation
- •Previous recent stroke
- •Creatinine clearance less than 30 ml/min
- •End stage liver disease (liver cirrhosis)
- •Drug dependance history
- •Untreated phaeochromocytoma
- •Vasospastic angina
- •Thyrotoxicosis
- •History of advanced staged of peripheral vascular disease
- •Hypersensitivity
- •Patients on any other beta-blocker other than bisoprolol
- •Patients on bisoprolol higher than 5 mg/day.
研究组 & 干预措施
Twice Daily Regimen
Experimental
Patients who take bisoprolol 2.5 mg twice per day.
干预措施: Bisoprolol (Drug)
Once Daily Regimen
Active Comparator
Patients who take bisoprolol 5 mg per day.
干预措施: Bisoprolol (Drug)
结局指标
主要结局
Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate
时间窗: 5 days
Incidence of Atrial Fibrillation
次要结局
- Hospital Mortality(Hospital Stay (up to 10 days))
- Onset time of Atrial Fibrillation(5 days)
- Mean reduction in heart rate(Hospital stay ( up to 10 days))
- Recurrence of Atrial Fibrillation(5 days)
- Bisoprolol concentration(time before next dose post average 24 hours)
- Medication safety(Hospital stay (up to 10 days))
- Use of inotropes/vasopressors(ICU stay (up to 5 days))
- Mean resting heart rate(Hospital stay ( up to 10 days))
- Mean systolic and diastolic blood pressure(Hospital stay (up to 10 days))
- Length of ICU stay(ICU stay (up to 5 days))
- Length of Hospital stay(Hospital stay (up to 10 days))
- ICU mortality(ICU stay (up to 5 days))
研究者
Reem Ihab Farouq
Teaching assistant
Cairo University
研究点 (1)
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