Atrial Fibrillation and By-pass Surgery

NCT ID: NCT01955759

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-02-28

Brief Summary

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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

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Conditions

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Patients With Coronary Artery Disease Scheduled for by Pass Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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beta blocker and amiodarone

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

Group Type EXPERIMENTAL

Amiodarone tab 200 mg x 3

Intervention Type DRUG

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

beta blockers Bisoprolol in adjusted dose

Intervention Type DRUG

starting 7 days befoe coronary by-pass surgery

beta blocker and statin

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.

Group Type EXPERIMENTAL

rosuvastatin 20 mg tab x1

Intervention Type DRUG

starting 7 days before coronary by-pass surgery

beta blockers Bisoprolol in adjusted dose

Intervention Type DRUG

starting 7 days befoe coronary by-pass surgery

beta blocker

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

Group Type PLACEBO_COMPARATOR

beta blockers Bisoprolol in adjusted dose

Intervention Type DRUG

starting 7 days befoe coronary by-pass surgery

Interventions

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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

Intervention Type DRUG

rosuvastatin 20 mg tab x1

starting 7 days before coronary by-pass surgery

Intervention Type DRUG

beta blockers Bisoprolol in adjusted dose

starting 7 days befoe coronary by-pass surgery

Intervention Type DRUG

Other Intervention Names

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cordarone crestor zebeta

Eligibility Criteria

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Inclusion Criteria

* significant coronary disease, sinus rhythm

Exclusion Criteria

* valvular disease, former by-pass surgery
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart Center BH Tuzla

OTHER

Sponsor Role lead

Responsible Party

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Enes Osmanović

Mr.med.sc.Dr Enes Osmanovic

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Heart Center BH

Tuzla, TK, Bosnia and Herzegovina

Site Status

Countries

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Bosnia and Herzegovina

Central Contacts

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Enes Osmanovic, Master's degree

Role: CONTACT

Phone: +387 66 725 744

Email: [email protected]

Goran Imamovic

Role: CONTACT

Email: [email protected]

Facility Contacts

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Enes Osmanović

Role: primary

Other Identifiers

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0115/09 - (2013)

Identifier Type: -

Identifier Source: org_study_id