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

Purpose

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

Condition	Intervention
Atrial Fibrillation	Drug: Amiodarone + Propranolol Drug: Amiodarone Drug: Propranolol

Genetics Home Reference related topics:

Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics:

Coronary Artery Bypass Surgery

ChemIDplus related topics:

Propranolol Dexpropranolol Propranolol hydrochloride Amiodarone Amidox Amiodarone hydrochloride

U.S. FDA Resources

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

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

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:

incidence of atrial fibrillation post CABG [ Time Frame: 7 days post CABG ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

bradycardia, mortality, hypotension, morbidity [ Time Frame: 7 days post CABG ] [ Designated as safety issue: Yes ]

Enrollment:	240
Study Start Date:	March 2007
Study Completion Date:	February 2008
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
P: Experimental Propranolol from 7 days pre-operation to 5 days post CABG	Drug: Propranolol Propranolol from 7 days pre-operation to 5 days post CABG
A: Active Comparator Amiodarone treated 7 days pre-operation to 5 days post CABG	Drug: Amiodarone Amiodarone treated 7 days pre-operation to 5 days post CABG
AP: Active Comparator 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

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.

Eligibility

Ages Eligible for Study:	45 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient who are going to have elective CABG
Signing informed consent

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00654290

Locations


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

Sponsors and Collaborators

Shiraz University of Medical Sciences

More Information

Responsible Party:	National Institute of Health ( shiraz university of medical sciences/Dr kojuri )
Study ID Numbers:	55318, NIH of IRAN
First Received:	April 2, 2008
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00654290
Health Authority:	Iran: National Institute of Health

Keywords provided by Shiraz University of Medical Sciences:

Atrial fibrillation

coronary bypass

Amiodarone

Propranolol

Coronary Artery Bypass Graft (CABG)

Study placed in the following topic categories:

Heart Diseases

Propranolol

Atrial Fibrillation

Amiodarone

Arrhythmias, Cardiac

Additional relevant MeSH terms:

Neurotransmitter Agents

Vasodilator Agents

Molecular Mechanisms of Pharmacological Action

Adrenergic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Cardiovascular Agents

Antihypertensive Agents

Pharmacologic Actions

Pathologic Processes

Therapeutic Uses

Adrenergic beta-Antagonists

Cardiovascular Diseases

Adrenergic Antagonists

Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Shiraz University of Medical Sciences
Information provided by:	Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00654290