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临床试验/NCT00654290
NCT00654290已完成不适用

Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft, A Prospective Double-Blind Randomized Study

Shiraz University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2007年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
incidence of atrial fibrillation post CABG

研究概览

简要总结

Atrial fibrillation is the most common arrhythmia post coronary bypass surgery, currently B-blockers are the class I indication to prevent AF post CABG. We decide to evaluate use of propranolol and amiodarone separately and together to find a better prophylaxis for AF peri-CABG

详细描述

In this double blind randomized study 240 consecutive patients underwent elective coronary artery bypass grafting, being randomized prospectively into three groups, propranolol (p) (n=80), amiodarone (A) (n=80) and amiodarone with propranolol (AP) (n=80).

All groups received their medications from 7 days preoperatively and continued their medications for 5 days post CABG.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
45 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who are going to have elective CABG
  • Signing informed consent

排除标准

  • Bradycardia<60 per min
  • Hypotension< 100 mmhg

研究组 & 干预措施

P

Experimental

Propranolol from 7 days pre-operation to 5 days post CABG

干预措施: Propranolol (Drug)

A

Active Comparator

Amiodarone treated 7 days pre-operation to 5 days post CABG

干预措施: Amiodarone (Drug)

AP

Active Comparator

Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG

干预措施: Amiodarone + Propranolol (Drug)

结局指标

主要结局

incidence of atrial fibrillation post CABG

时间窗: 7 days post CABG

次要结局

  • bradycardia, mortality, hypotension, morbidity(7 days post CABG)

研究者

申办方类型
Other

研究点 (1)

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