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

Atrial Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00654290
• Other study ID #: 55318
• Secondary ID: NIH of IRAN
• Status: Completed
• Phase: N/A
• First received: April 2, 2008
• Last updated: April 4, 2008
• Start date: March 2007
• Est. completion date: February 2008

Study information

• Verified date: April 2008
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: National Institute of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: February 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences/Cardiac Surgery and Cardiology Ward/Namazi and Shahid Faghihi Hospital	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of atrial fibrillation post CABG		7 days post CABG	Yes
Secondary	bradycardia, mortality, hypotension, morbidity		7 days post CABG	Yes