search
Back to results

Atrial Fibrillation and By-pass Surgery

Primary Purpose

Patients With Coronary Artery Disease Scheduled for by Pass Surgery

Status
Unknown status
Phase
Early Phase 1
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
Amiodarone tab 200 mg x 3
rosuvastatin 20 mg tab x1
beta blockers Bisoprolol in adjusted dose
Sponsored by
Heart Center BH Tuzla
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Patients With Coronary Artery Disease Scheduled for by Pass Surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • significant coronary disease, sinus rhythm

Exclusion Criteria:

  • valvular disease, former by-pass surgery

Sites / Locations

  • Heart Center BH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

beta blocker and amiodarone

beta blocker and statin

beta blocker

Arm 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

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.

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

Outcomes

Primary Outcome Measures

atrial fibrillation
outcome will be number of patients free from atrial fibrillation.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2013
Last Updated
December 15, 2013
Sponsor
Heart Center BH Tuzla
search

1. Study Identification

Unique Protocol Identification Number
NCT01955759
Brief Title
Atrial Fibrillation and By-pass Surgery
Official Title
Pharmacologic Prophylaxis for Atrial Fibrillation Following Coronary By-Pass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
February 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Heart Center BH Tuzla

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Coronary Artery Disease Scheduled for by Pass Surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
beta blocker and amiodarone
Arm Type
Experimental
Arm 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
Arm Title
beta blocker and statin
Arm Type
Experimental
Arm 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.
Arm Title
beta blocker
Arm Type
Placebo Comparator
Arm Description
Patients will receive beta blocker (Bisoprolol tab in adjusted dose).
Intervention Type
Drug
Intervention Name(s)
Amiodarone tab 200 mg x 3
Other Intervention Name(s)
cordarone
Intervention Description
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
Intervention Name(s)
rosuvastatin 20 mg tab x1
Other Intervention Name(s)
crestor
Intervention Description
starting 7 days before coronary by-pass surgery
Intervention Type
Drug
Intervention Name(s)
beta blockers Bisoprolol in adjusted dose
Other Intervention Name(s)
zebeta
Intervention Description
starting 7 days befoe coronary by-pass surgery
Primary Outcome Measure Information:
Title
atrial fibrillation
Description
outcome will be number of patients free from atrial fibrillation.
Time Frame
10 days on average during hospital stay after coronary by-pass surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: significant coronary disease, sinus rhythm Exclusion Criteria: valvular disease, former by-pass surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enes Osmanovic, Master's degree
Phone
+387 66 725 744
Email
osmanovic@bhsrce.ba
First Name & Middle Initial & Last Name or Official Title & Degree
Goran Imamovic
Email
goran.imamovic@fmc-ag.com
Facility Information:
Facility Name
Heart Center BH
City
Tuzla
State/Province
TK
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enes Osmanović
Phone
+387 66 725 744
Email
osmanovic@bih.net.ba

12. IPD Sharing Statement

Learn more about this trial

Atrial Fibrillation and By-pass Surgery

We'll reach out to this number within 24 hrs