Atrial Fibrillation and By-pass Surgery

December 15, 2013 updated by: Enes Osmanović, Heart Center BH Tuzla

Pharmacologic Prophylaxis for Atrial Fibrillation Following Coronary By-Pass Surgery

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

260

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Enes Osmanovic, Master's degree
  • Phone Number: +387 66 725 744
  • Email: osmanovic@bhsrce.ba

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • significant coronary disease, sinus rhythm

Exclusion Criteria:

  • valvular disease, former by-pass surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
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
Other Names:
  • cordarone
Drug: beta blockers Bisoprolol in adjusted dose
starting 7 days befoe coronary by-pass surgery
Other Names:
  • zebeta
EXPERIMENTAL: 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.
Drug: beta blockers Bisoprolol in adjusted dose
starting 7 days befoe coronary by-pass surgery
Other Names:
  • zebeta
Drug: rosuvastatin 20 mg tab x1
starting 7 days before coronary by-pass surgery
Other Names:
  • crestor
PLACEBO_COMPARATOR: beta blocker
Patients will receive beta blocker (Bisoprolol tab in adjusted dose).
Drug: beta blockers Bisoprolol in adjusted dose
starting 7 days befoe coronary by-pass surgery
Other Names:
  • zebeta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
atrial fibrillation
Time Frame: 10 days on average during hospital stay after coronary by-pass surgery
outcome will be number of patients free from atrial fibrillation.
10 days on average during hospital stay after coronary by-pass surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Heart Center BH Tuzla

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

February 1, 2015

Study Registration Dates

First Submitted

September 21, 2013

First Submitted That Met QC Criteria

September 29, 2013

First Posted (ESTIMATE)

October 7, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 15, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0115/09 - (2013)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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