Official Title: “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”

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

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: January 2008

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.

Intervention(s) in this Clinical Trial

• Drug: Amiodarone + Propranolol
  • Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG
• Drug: Amiodarone
  • Amiodarone treated 7 days pre-operation to 5 days post CABG
• Drug: Propranolol
  • Propranolol from 7 days pre-operation to 5 days post CABG

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: P
  • Propranolol from 7 days pre-operation to 5 days post CABG
• Active Comparator: A
  • Amiodarone treated 7 days pre-operation to 5 days post CABG
• Active Comparator: AP
  • Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG

Primary Measures

• incidence of atrial fibrillation post CABG
  • Time Frame: 7 days post CABG
    Safety Issue?: Yes

Secondary Measures

• bradycardia, mortality, hypotension, morbidity
  • Time Frame: 7 days post CABG
    Safety Issue?: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• EF<35%
• Bradycardia<60 per min
• Hypotension< 100 mmhg

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Shiraz University of Medical Sciences

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00654290

Study ID Number: 55318

ClinicalTrials.gov Identifier: NCT00654290

Health Authority: Iran: National Institute of Health