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Atrial Fibrillation and By-pass Surgery

H

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

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

Trial contacts and locations

1

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Central trial contact

Goran Imamovic; Enes Osmanovic, Master's degree

Data sourced from clinicaltrials.gov

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