Atrial Fibrillation and By-pass Surgery

Heart Center BH Tuzla

Status and phase: Unknown; Early Phase 1

Conditions: Patients With Coronary Artery Disease Scheduled for by Pass Surgery

Treatments: Drug: beta blockers Bisoprolol in adjusted dose; Drug: rosuvastatin 20 mg tab x1; Drug: Amiodarone tab 200 mg x 3

Study type: Interventional

Funder types: Other

Identifiers

NCT01955759

0115/09 - (2013)

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• significant coronary disease, sinus rhythm

Exclusion criteria

• valvular disease, former by-pass surgery

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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260 participants in 3 patient groups, including a placebo group

beta blocker and amiodarone

Experimental group

Description:

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

Treatment:

Drug: Amiodarone tab 200 mg x 3

Drug: beta blockers Bisoprolol in adjusted dose

beta blocker and statin

Experimental group

Description:

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.

Treatment:

Drug: rosuvastatin 20 mg tab x1

Drug: beta blockers Bisoprolol in adjusted dose

beta blocker

Placebo Comparator group

Description:

Patients will receive beta blocker (Bisoprolol tab in adjusted dose).

Treatment:

Drug: beta blockers Bisoprolol in adjusted dose