Atrial Fibrillation and By-pass Surgery

Patients With Coronary Artery Disease Scheduled for by Pass Surgery Clinical Trial

Official title:

Pharmacologic Prophylaxis for Atrial Fibrillation Following Coronary By-Pass Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01955759
• Other study ID #: 0115/09 - (2013)
• Status: Not yet recruiting
• Phase: Phase 0
• First received: September 21, 2013
• Last updated: December 15, 2013
• Start date: December 2013
• Est. completion date: February 2015

Study information

• Verified date: December 2013
• Source: Heart Center BH Tuzla
• Contact: Enes Osmanovic, Master's degree
• Phone: +387 66 725 744
• Email: osmanovic[@]bhsrce.ba
• Is FDA regulated: No
• Health authority: Bosnia and Herzegovina: Federal Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to evaluate whether combined therapy with beta-blocker, amiodarone and statine is better than beta-blocker alone for the prevention of atrial fibrillation after coronary by-pass surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: February 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• significant coronary disease, sinus rhythm

Exclusion Criteria:

• valvular disease, former by-pass surgery

Study Design

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Patients With Coronary Artery Disease Scheduled for by Pass Surgery

Intervention

Drug:
• Amiodarone tab 200 mg x 3
starting 7 days before coronary by-pass surgery per os 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge
• rosuvastatin 20 mg tab x1
starting 7 days before coronary by-pass surgery
• beta blockers Bisoprolol in adjusted dose
starting 7 days befoe coronary by-pass surgery

Locations

Country	Name	City	State
Bosnia and Herzegovina	Heart Center BH	Tuzla	TK

Sponsors (1)

Lead Sponsor	Collaborator
Heart Center BH Tuzla

Country where clinical trial is conducted

Bosnia and Herzegovina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	atrial fibrillation	outcome will be number of patients free from atrial fibrillation.	10 days on average during hospital stay after coronary by-pass surgery	No