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

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.

Study Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Postoperative Atrial Fibrillation; Coronary Artery Bypass Grafting
• Intervention / Treatment: Drug: Bisoprolol; Drug: Bisoprolol

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Reem Ihab, Bsc; Phone Number: +0201144481391; Email: reem.ihab@pharma.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • El-Demerdash Cardiac Academy Hospital
    • Contact: Reem Ihab, Bsc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Reem Ihab, Bsc, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2021
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): September 1, 2023

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 15, 2023

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: blood pressure; Bisoprolol; heart rate; Dosage regimens
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Coronary Disease; Coronary Artery Disease; Atrial Fibrillation; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Autonomic Agents; Peripheral Nervous System Agents; Sympatholytics; Adrenergic beta-1 Receptor Antagonists; Bisoprolol
• Other Study ID Numbers: CL(2776)

Drug and device information, study documents

• 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