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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05730413

Collaborator

(none)

122

Enrollment

Location

Arms

8.2

Anticipated Duration (Months)

14.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Bypass Grafting Postoperative Atrial Fibrillation Coronary Artery Disease	Drug: Bisoprolol Drug: Bisoprolol	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

122 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Aug 25, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Once Daily Regimen Patients who take bisoprolol 5 mg per day.	Drug: Bisoprolol Bisoprolol was taken as 5 mg per day from hospital admission till discharge.
Experimental: Twice Daily Regimen Patients who take bisoprolol 2.5 mg twice per day.	Drug: Bisoprolol Bisoprolol dose was divided to be taken as 2.5 mg twice per day from hospital admission to discharge.

Arm

Intervention/Treatment

Active Comparator: Once Daily Regimen

Patients who take bisoprolol 5 mg per day.

Drug: Bisoprolol

Bisoprolol was taken as 5 mg per day from hospital admission till discharge.

Experimental: Twice Daily Regimen

Patients who take bisoprolol 2.5 mg twice per day.

Drug: Bisoprolol

Bisoprolol dose was divided to be taken as 2.5 mg twice per day from hospital admission to discharge.

Outcome Measures

Primary Outcome Measures

Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate [5 days]
Incidence of Atrial Fibrillation

Secondary Outcome Measures

Onset time of Atrial Fibrillation [5 days]
Time at which event happened.
Recurrence of Atrial Fibrillation [5 days]
Time at which event recurred.
Mean reduction in heart rate [Hospital stay ( up to 10 days)]
Mean of reduction between two arms.
Mean resting heart rate [Hospital stay ( up to 10 days)]
mean resting heart rate between two arms.
Mean systolic and diastolic blood pressure [Hospital stay (up to 10 days)]
Mean systolic and diastolic blood pressure between two arms.
Length of ICU stay [ICU stay (up to 5 days)]
time spent in the from ICU admission to ICU discharge
Length of Hospital stay [Hospital stay (up to 10 days)]
time spent in the hospital till discharge
Medication safety [Hospital stay (up to 10 days)]
Any symptom which requires dose lowering or discontinuation of bisoprolol e.g hypotension episodes
Bisoprolol concentration [time before next dose post average 24 hours]
Bisoprolol concentration between two arms
Use of inotropes/vasopressors [ICU stay (up to 5 days)]
compare use of inotropes/vasopressors between the two arms.
ICU mortality [ICU stay (up to 5 days)]
Number of death during ICU stay
Hospital Mortality [Hospital Stay (up to 10 days)]
Number of death during hospital stay

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.