Atrial Fibrillation and By-pass Surgery

Early Phase 1

• Conditions: Patients With Coronary Artery Disease Scheduled for by Pass Surgery
• Interventions: Drug: Amiodarone tab 200 mg x 3; Drug: rosuvastatin 20 mg tab x1; Drug: beta blockers Bisoprolol in adjusted dose

• Registration Number: NCT01955759
• Lead Sponsor: Heart Center BH Tuzla

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-21
• Study First Submitted QC: 2013-09-29
• Study First Posted: 2013-10-07
• Status Verified: 2013-12
• Study Start: 2013-12
• Last Update Submitted: 2013-12-15
• Last Update Posted: 2013-12-17
• Primary Completion: 2014-12
• Study Completion: 2015-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• significant coronary disease, sinus rhythm

Exclusion Criteria

• valvular disease, former by-pass surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
beta blocker and amiodarone	Amiodarone tab 200 mg x 3	The inteventin will be that patients will receive beta blocker Bisoprolol in adjusted dose + Amiodarone per os starting 7 days before coronary by-pass surgery, 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge
beta blocker and amiodarone	beta blockers Bisoprolol in adjusted dose	The inteventin will be that patients will receive beta blocker Bisoprolol in adjusted dose + Amiodarone per os starting 7 days before coronary by-pass surgery, 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge
beta blocker and statin	rosuvastatin 20 mg tab x1	The intervention will be that patients will receive beta blocker (Bisoprolol tab in adjusted dose)+ Rosuvastatin 20 mg. x 1 starting 7 days before coronary by-pass surgry untill discharge.
beta blocker and statin	beta blockers Bisoprolol in adjusted dose	The intervention will be that patients will receive beta blocker (Bisoprolol tab in adjusted dose)+ Rosuvastatin 20 mg. x 1 starting 7 days before coronary by-pass surgry untill discharge.
beta blocker	beta blockers Bisoprolol in adjusted dose	Patients will receive beta blocker (Bisoprolol tab in adjusted dose).

Primary Outcome Measures

Name	Time	Method
atrial fibrillation	10 days on average during hospital stay after coronary by-pass surgery	outcome will be number of patients free from atrial fibrillation.

Trial Locations

Locations (1)

Heart Center BH; 🇧🇦 Tuzla, TK, Bosnia and Herzegovina