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

Cairo University (CU)

Status and phase: Enrolling; Phase 4

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

Treatments: Drug: Bisoprolol

Study type: Interventional

Funder types: Other

Identifiers

NCT05730413

CL(2776)

Details and patient eligibility

About

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.

Enrollment: 122 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

122 participants in 2 patient groups

Once Daily Regimen

Active Comparator group

Description:

Patients who take bisoprolol 5 mg per day.

Treatment:

Drug: Bisoprolol

Drug: Bisoprolol

Twice Daily Regimen

Experimental group

Description:

Patients who take bisoprolol 2.5 mg twice per day.

Treatment:

Drug: Bisoprolol

Drug: Bisoprolol