Effect of Prophylaxy of Amiodarone and Propranolol and Amiodarone With Propranolol in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft

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 Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Propranolol; Drug: Amiodarone; Drug: Amiodarone + Propranolol

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Fars
    • Shiraz, Fars, Iran, Islamic Republic of, 71345
      • Shiraz University of Medical Sciences/Cardiac Surgery and Cardiology Ward/Namazi and Shahid Faghihi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: P; Propranolol from 7 days pre-operation to 5 days post CABG	Drug: Propranolol; 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	Drug: Amiodarone; 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	Drug: Amiodarone + Propranolol; Amiodarone and Propranolol 7 days pre-operation to 5 days post CABG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of atrial fibrillation post CABG	7 days post CABG

Secondary Outcome Measures

Outcome Measure	Time Frame
bradycardia, mortality, hypotension, morbidity	7 days post CABG

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences

Publications and helpful links

General Publications

• Kojuri J, Mahmoodi Y, Jannati M, Shafa M, Ghazinoor M, Sharifkazemi MB. Ability of amiodarone and propranolol alone or in combination to prevent post-coronary bypass atrial fibrillation. Cardiovasc Ther. 2009 Winter;27(4):253-8. doi: 10.1111/j.1755-5922.2009.00100.x.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): January 1, 2008
• Study Completion (Actual): February 1, 2008

Study Registration Dates

• First Submitted: April 2, 2008
• First Submitted That Met QC Criteria: April 4, 2008
• First Posted (Estimate): April 7, 2008

Study Record Updates

• Last Update Posted (Estimate): April 7, 2008
• Last Update Submitted That Met QC Criteria: April 4, 2008
• Last Verified: April 1, 2008

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Propranolol; Amiodarone; coronary bypass; Coronary Artery Bypass Graft (CABG)
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Enzyme Inhibitors; Membrane Transport Modulators; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Sodium Channel Blockers; Cytochrome P-450 CYP2D6 Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Cytochrome P-450 CYP2C9 Inhibitors; Potassium Channel Blockers; Propranolol; Amiodarone
• Other Study ID Numbers: 55318; NIH of IRAN