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

NCT ID: NCT00654290

Last Updated: 2008-04-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-02-29

Brief Summary

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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

Detailed Description

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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.

Conditions

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Atrial Fibrillation

Keywords

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Atrial fibrillation coronary bypass Amiodarone Propranolol Coronary Artery Bypass Graft (CABG)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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P

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

Group Type EXPERIMENTAL

Propranolol

Intervention Type DRUG

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

A

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

Group Type ACTIVE_COMPARATOR

Amiodarone

Intervention Type DRUG

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

AP

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

Group Type ACTIVE_COMPARATOR

Amiodarone + Propranolol

Intervention Type DRUG

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

Interventions

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Amiodarone + Propranolol

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

Intervention Type DRUG

Amiodarone

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

Intervention Type DRUG

Propranolol

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* EF\<35%
* Bradycardia\<60 per min
* Hypotension\< 100 mmhg
Minimum Eligible Age

45 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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National Institute of Health

Locations

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Shiraz University of Medical Sciences/Cardiac Surgery and Cardiology Ward/Namazi and Shahid Faghihi Hospital

Shiraz, Fars, Iran

Site Status

Countries

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Iran

References

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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.

Reference Type DERIVED
PMID: 19903189 (View on PubMed)

Other Identifiers

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NIH of IRAN

Identifier Type: -

Identifier Source: secondary_id

55318

Identifier Type: -

Identifier Source: org_study_id