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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Bisoprolol
* Drug: Bisoprolol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate | Incidence of Atrial Fibrillation | 5 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bisoprolol, Dosage regimens, heart rate, blood pressure