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

NCT05730413 | Unknown Phase 4

• 1 other identifier: CL(2776)
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Bisoprolol; Dosage regimens; heart rate; blood pressure

Outcome Measures

Primary Outcomes (1)

• Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate

  Incidence of Atrial Fibrillation

  5 days

Secondary Outcomes (12)

• Onset time of Atrial Fibrillation

  5 days

• Recurrence of Atrial Fibrillation

  5 days

• Mean reduction in heart rate

  Hospital stay ( up to 10 days)

• Mean resting heart rate

  Hospital stay ( up to 10 days)

• Mean systolic and diastolic blood pressure

  Hospital stay (up to 10 days)

Study Arms (2)

Once Daily Regimen

ACTIVE COMPARATOR

Patients who take bisoprolol 5 mg per day.

Drug: Bisoprolol

Twice Daily Regimen

EXPERIMENTAL

Patients who take bisoprolol 2.5 mg twice per day.

Drug: Bisoprolol

Interventions

Bisoprolol DRUG

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

Twice Daily Regimen

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients: 18 to 65 years old
• Diagnosed with coronary heart disease or myocardial infarction and scheduled for coronary artery bypass surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

El-Demerdash Cardiac Academy Hospital

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Bisoprolol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Reem Ihab, Bsc

  Cairo University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reem Ihab, Bsc

CONTACT

+0201144481391; reem.ihab@pharma.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 15, 2023
• Study Start: August 25, 2021
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

EG (1)