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

NCT ID: NCT05730413

Last Updated: 2023-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2023-09-30

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.

Detailed Description

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Conditions

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Coronary Artery Bypass Grafting Postoperative Atrial Fibrillation Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Once Daily Regimen

Patients who take bisoprolol 5 mg per day.

Group Type ACTIVE_COMPARATOR

Bisoprolol

Intervention Type DRUG

Bisoprolol was taken as 5 mg per day from hospital admission till discharge.

Twice Daily Regimen

Patients who take bisoprolol 2.5 mg twice per day.

Group Type EXPERIMENTAL

Bisoprolol

Intervention Type DRUG

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

Interventions

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Bisoprolol

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

Intervention Type DRUG

Bisoprolol

Bisoprolol was taken as 5 mg per day from hospital admission till discharge.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Reem Ihab Farouq

Teaching assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Reem Ihab, Bsc

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

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El-Demerdash Cardiac Academy Hospital

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Reem Ihab, Bsc

Role: CONTACT

+0201144481391

Facility Contacts

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Reem Ihab, Bsc

Role: primary

Other Identifiers

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CL(2776)

Identifier Type: -

Identifier Source: org_study_id

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