Coronary Artery Bypass GraftingPhase 4NCT05730413
Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery
A Phase 4 study testing Bisoprolol in people with Coronary Artery Bypass Grafting and Postoperative Atrial Fibrillation, run by Cairo University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coronary Artery Bypass Grafting, Postoperative Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- Bisoprolol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Aug 2021to Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients: 18 to 65 years old
- Diagnosed with coronary heart disease or myocardial infarction and scheduled for coronary artery bypass surgery
Who cannot join
- 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
Show all 23Show fewer
- 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 locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
El-Demerdash Cardiac Academy Hospital
Cairo
Reem Ihab, Bsc
About this study
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
- Being tested
- Bisoprolol
- Keywords
- Bisoprolol, Dosage regimens, heart rate, blood pressure
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BisoprololDrug
Bisoprolol dose was divided to be taken as 2.5 mg twice per day from hospital admission to discharge.
BisoprololDrug
Bisoprolol was taken as 5 mg per day from hospital admission till discharge.
| Study group | Role | What they receive |
|---|---|---|
| Once Daily Regimen | Active comparator | Patients who take bisoprolol 5 mg per day. Receives: Drug: Bisoprolol |
| Twice Daily Regimen | Experimental | Patients who take bisoprolol 2.5 mg twice per day. Receives: Drug: Bisoprolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate
Incidence of Atrial Fibrillation
Measured: 5 days
Secondary outcomes (12)
Onset time of Atrial Fibrillation
Time at which event happened.
Measured: 5 days
Recurrence of Atrial Fibrillation
Time at which event recurred.
Measured: 5 days
Mean reduction in heart rate
Mean of reduction between two arms.
Measured: Hospital stay ( up to 10 days)
Mean resting heart rate
mean resting heart rate between two arms.
Measured: Hospital stay ( up to 10 days)
Mean systolic and diastolic blood pressure
Mean systolic and diastolic blood pressure between two arms.
Measured: Hospital stay (up to 10 days)
Length of ICU stay
time spent in the from ICU admission to ICU discharge
Measured: ICU stay (up to 5 days)
Length of Hospital stay
time spent in the hospital till discharge
Measured: Hospital stay (up to 10 days)
Medication safety
Any symptom which requires dose lowering or discontinuation of bisoprolol e.g hypotension episodes
Measured: Hospital stay (up to 10 days)
Bisoprolol concentration
Bisoprolol concentration between two arms
Measured: time before next dose post average 24 hours
Use of inotropes/vasopressors
compare use of inotropes/vasopressors between the two arms.
Measured: ICU stay (up to 5 days)
ICU mortality
Number of death during ICU stay
Measured: ICU stay (up to 5 days)
Hospital Mortality
Number of death during hospital stay
Measured: Hospital Stay (up to 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start25 Aug 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass GraftingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reem Ihab Farouq, Cairo University
- Investigators
- Reem Ihab, Bsc, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730413
- Sponsor's protocol ID
- CL(2776)
- Status last verified
- Jul 2023
- First submitted
- 27 Jan 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Once Versus Twice Bisoprolol Dosage Regimen in Prevention of Atrial Fibrillation Post Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT05730413
- Acronym / sponsor ID
- CL(2776)
- Conditions
- Coronary Artery Bypass Grafting, Postoperative Atrial Fibrillation, Coronary Artery Disease
- Keywords
- Bisoprolol, Dosage regimens, heart rate, blood pressure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 15 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once Daily Regimen | Active comparator | Drug: BisoprololPatients who take bisoprolol 5 mg per day. |
| Twice Daily Regimen | Experimental | Drug: BisoprololPatients who take bisoprolol 2.5 mg twice per day. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients: 18 to 65 years old
- Diagnosed with coronary heart disease or myocardial infarction and scheduled for coronary artery bypass surgery
Key exclusion criteria (23 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BisoprololBisoprolol dose was divided to be taken as 2.5 mg twice per day from hospital admission to discharge. | Drug | Twice Daily Regimen |
| BisoprololBisoprolol was taken as 5 mg per day from hospital admission till discharge. | Drug | Once Daily Regimen |
Primary outcome
Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate
Time frame: 5 days
Incidence of Atrial Fibrillation
12 secondary outcomes
Onset time of Atrial Fibrillation
Time frame: 5 days
Recurrence of Atrial Fibrillation
Time frame: 5 days
Mean reduction in heart rate
Time frame: Hospital stay ( up to 10 days)
Mean resting heart rate
Time frame: Hospital stay ( up to 10 days)
Mean systolic and diastolic blood pressure
Time frame: Hospital stay (up to 10 days)
Length of ICU stay
Time frame: ICU stay (up to 5 days)
Length of Hospital stay
Time frame: Hospital stay (up to 10 days)
Medication safety
Time frame: Hospital stay (up to 10 days)
Bisoprolol concentration
Time frame: time before next dose post average 24 hours
Use of inotropes/vasopressors
Time frame: ICU stay (up to 5 days)
ICU mortality
Time frame: ICU stay (up to 5 days)
Hospital Mortality
Time frame: Hospital Stay (up to 10 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem Ihab, Bsc principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bisoprolol in people with Coronary Artery Bypass Grafting and Postoperative Atrial Fibrillation, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reem Ihab, Bsc (+0201144481391, reem.ihab@pharma.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevention of postoperative Atrial fibrillation without normal blood pressure and/or heart rate (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.