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

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

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Coronary Artery Bypass Surgery Surgery

Drug Information available for: Amiodarone hydrochloride Amidox Propranolol hydrochloride Propranolol Amiodarone Dexpropranolol

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:

Neurotransmitter Agents
Vasodilator Agents
Heart Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Amiodarone

Pharmacologic Actions
Pathologic Processes
Propranolol
Therapeutic Uses
Adrenergic beta-Antagonists
Adrenergic Antagonists
Cardiovascular Diseases
Atrial Fibrillation
Anti-Arrhythmia Agents
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 09, 2009