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Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery

Primary Purpose

Coronary Artery Bypass Grafting, Postoperative Atrial Fibrillation, Coronary Artery Disease

Status
Recruiting
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Bisoprolol
Bisoprolol
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Bypass Grafting focused on measuring Bisoprolol, Dosage regimens, heart rate, blood pressure

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Adult patients: 18 to 65 years old Diagnosed with coronary heart disease or myocardial infarction and scheduled for coronary artery bypass surgery Exclusion Criteria: History of Ventricular arrhythmia, atrial fibrillation, atrial flutter, left bundle block, AV block grade II/III History of Sick sinus syndrome, sinoatrial heart block History of valve replacement Permanent Pacemaker LVEF less than 30% Unstable Heart failure Cardiogenic shock Sustained systolic blood pressure less than 100 mmHg or HR less than 50 bpm at recruitment Severe chronic obstructive airway disease Severe asthma unless was on previously tolerated bisoprolol dose Uncontrolled diabetes mellitus unless was on previously tolerated bisoprolol dose Pregnant/Lactation Previous recent stroke Creatinine clearance less than 30 ml/min End stage liver disease (liver cirrhosis) Drug dependance history Untreated phaeochromocytoma Vasospastic angina Thyrotoxicosis History of advanced staged of peripheral vascular disease Hypersensitivity Patients on any other beta-blocker other than bisoprolol Patients on bisoprolol higher than 5 mg/day.

Sites / Locations

  • El-Demerdash Cardiac Academy HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Once Daily Regimen

Twice Daily Regimen

Arm Description

Patients who take bisoprolol 5 mg per day.

Patients who take bisoprolol 2.5 mg twice per day.

Outcomes

Primary Outcome Measures

Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate
Incidence of Atrial Fibrillation

Secondary Outcome Measures

Onset time of Atrial Fibrillation
Time at which event happened.
Recurrence of Atrial Fibrillation
Time at which event recurred.
Mean reduction in heart rate
Mean of reduction between two arms.
Mean resting heart rate
mean resting heart rate between two arms.
Mean systolic and diastolic blood pressure
Mean systolic and diastolic blood pressure between two arms.
Length of ICU stay
time spent in the from ICU admission to ICU discharge
Length of Hospital stay
time spent in the hospital till discharge
Medication safety
Any symptom which requires dose lowering or discontinuation of bisoprolol e.g hypotension episodes
Bisoprolol concentration
Bisoprolol concentration between two arms
Use of inotropes/vasopressors
compare use of inotropes/vasopressors between the two arms.
ICU mortality
Number of death during ICU stay
Hospital Mortality
Number of death during hospital stay

Full Information

First Posted
January 27, 2023
Last Updated
July 26, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05730413
Brief Title
Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery
Official Title
Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this interventional clinical trial is compare between two different dose regimens of bisoprolol (beta-blocker) in CABG patients in terms of efficacy and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Bypass Grafting, Postoperative Atrial Fibrillation, Coronary Artery Disease
Keywords
Bisoprolol, Dosage regimens, heart rate, blood pressure

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Once Daily Regimen
Arm Type
Active Comparator
Arm Description
Patients who take bisoprolol 5 mg per day.
Arm Title
Twice Daily Regimen
Arm Type
Experimental
Arm Description
Patients who take bisoprolol 2.5 mg twice per day.
Intervention Type
Drug
Intervention Name(s)
Bisoprolol
Intervention Description
Bisoprolol dose was divided to be taken as 2.5 mg twice per day from hospital admission to discharge.
Intervention Type
Drug
Intervention Name(s)
Bisoprolol
Intervention Description
Bisoprolol was taken as 5 mg per day from hospital admission till discharge.
Primary Outcome Measure Information:
Title
Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate
Description
Incidence of Atrial Fibrillation
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Onset time of Atrial Fibrillation
Description
Time at which event happened.
Time Frame
5 days
Title
Recurrence of Atrial Fibrillation
Description
Time at which event recurred.
Time Frame
5 days
Title
Mean reduction in heart rate
Description
Mean of reduction between two arms.
Time Frame
Hospital stay ( up to 10 days)
Title
Mean resting heart rate
Description
mean resting heart rate between two arms.
Time Frame
Hospital stay ( up to 10 days)
Title
Mean systolic and diastolic blood pressure
Description
Mean systolic and diastolic blood pressure between two arms.
Time Frame
Hospital stay (up to 10 days)
Title
Length of ICU stay
Description
time spent in the from ICU admission to ICU discharge
Time Frame
ICU stay (up to 5 days)
Title
Length of Hospital stay
Description
time spent in the hospital till discharge
Time Frame
Hospital stay (up to 10 days)
Title
Medication safety
Description
Any symptom which requires dose lowering or discontinuation of bisoprolol e.g hypotension episodes
Time Frame
Hospital stay (up to 10 days)
Title
Bisoprolol concentration
Description
Bisoprolol concentration between two arms
Time Frame
time before next dose post average 24 hours
Title
Use of inotropes/vasopressors
Description
compare use of inotropes/vasopressors between the two arms.
Time Frame
ICU stay (up to 5 days)
Title
ICU mortality
Description
Number of death during ICU stay
Time Frame
ICU stay (up to 5 days)
Title
Hospital Mortality
Description
Number of death during hospital stay
Time Frame
Hospital Stay (up to 10 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult patients: 18 to 65 years old Diagnosed with coronary heart disease or myocardial infarction and scheduled for coronary artery bypass surgery Exclusion Criteria: History of Ventricular arrhythmia, atrial fibrillation, atrial flutter, left bundle block, AV block grade II/III History of Sick sinus syndrome, sinoatrial heart block History of valve replacement Permanent Pacemaker LVEF less than 30% Unstable Heart failure Cardiogenic shock Sustained systolic blood pressure less than 100 mmHg or HR less than 50 bpm at recruitment Severe chronic obstructive airway disease Severe asthma unless was on previously tolerated bisoprolol dose Uncontrolled diabetes mellitus unless was on previously tolerated bisoprolol dose Pregnant/Lactation Previous recent stroke Creatinine clearance less than 30 ml/min End stage liver disease (liver cirrhosis) Drug dependance history Untreated phaeochromocytoma Vasospastic angina Thyrotoxicosis History of advanced staged of peripheral vascular disease Hypersensitivity Patients on any other beta-blocker other than bisoprolol Patients on bisoprolol higher than 5 mg/day.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reem Ihab, Bsc
Phone
+0201144481391
Email
reem.ihab@pharma.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reem Ihab, Bsc
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
El-Demerdash Cardiac Academy Hospital
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reem Ihab, Bsc

12. IPD Sharing Statement

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Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery

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