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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730413
• Other study ID #: CL(2776)
• Status: Recruiting
• Phase: Phase 4
• Start date: August 25, 2021
• Est. completion date: September 2023

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: Reem Ihab, Bsc
• Phone: +0201144481391
• Email: reem.ihab[@]pharma.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Bisoprolol
Bisoprolol dose was divided to be taken as 2.5 mg twice per day from hospital admission to discharge.
• Bisoprolol
Bisoprolol was taken as 5 mg per day from hospital admission till discharge.

Locations

Country	Name	City	State
Egypt	El-Demerdash Cardiac Academy Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate	Incidence of Atrial Fibrillation	5 days
Secondary	Onset time of Atrial Fibrillation	Time at which event happened.	5 days
Secondary	Recurrence of Atrial Fibrillation	Time at which event recurred.	5 days
Secondary	Mean reduction in heart rate	Mean of reduction between two arms.	Hospital stay ( up to 10 days)
Secondary	Mean resting heart rate	mean resting heart rate between two arms.	Hospital stay ( up to 10 days)
Secondary	Mean systolic and diastolic blood pressure	Mean systolic and diastolic blood pressure between two arms.	Hospital stay (up to 10 days)
Secondary	Length of ICU stay	time spent in the from ICU admission to ICU discharge	ICU stay (up to 5 days)
Secondary	Length of Hospital stay	time spent in the hospital till discharge	Hospital stay (up to 10 days)
Secondary	Medication safety	Any symptom which requires dose lowering or discontinuation of bisoprolol e.g hypotension episodes	Hospital stay (up to 10 days)
Secondary	Bisoprolol concentration	Bisoprolol concentration between two arms	time before next dose post average 24 hours
Secondary	Use of inotropes/vasopressors	compare use of inotropes/vasopressors between the two arms.	ICU stay (up to 5 days)
Secondary	ICU mortality	Number of death during ICU stay	ICU stay (up to 5 days)
Secondary	Hospital Mortality	Number of death during hospital stay	Hospital Stay (up to 10 days)