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

Phase 4

Recruiting

• Conditions: Coronary Artery Bypass Grafting; Postoperative Atrial Fibrillation; Coronary Artery Disease
• Interventions: Drug: Bisoprolol

• Registration Number: NCT05730413
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-25
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-02-13
• Study First Posted: 2023-02-15
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28
• Primary Completion: 2023-09
• Study Completion: 2023-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 122

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Once Daily Regimen	Bisoprolol	Patients who take bisoprolol 5 mg per day.
Twice Daily Regimen	Bisoprolol	Patients who take bisoprolol 2.5 mg twice per day.

Primary Outcome Measures

Name	Time	Method
Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate	5 days	Incidence of Atrial Fibrillation

Secondary Outcome Measures

Name	Time	Method
Bisoprolol concentration	time before next dose post average 24 hours	Bisoprolol concentration between two arms
Hospital Mortality	Hospital Stay (up to 10 days)	Number of death during hospital stay
Onset time of Atrial Fibrillation	5 days	Time at which event happened.
Mean reduction in heart rate	Hospital stay ( up to 10 days)	Mean of reduction between two arms.
Recurrence of Atrial Fibrillation	5 days	Time at which event recurred.
Medication safety	Hospital stay (up to 10 days)	Any symptom which requires dose lowering or discontinuation of bisoprolol e.g hypotension episodes
Use of inotropes/vasopressors	ICU stay (up to 5 days)	compare use of inotropes/vasopressors between the 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
ICU mortality	ICU stay (up to 5 days)	Number of death during ICU stay

Trial Locations

Locations (1)

El-Demerdash Cardiac Academy Hospital; 🇪🇬 Cairo, Egypt