Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202103543569729 Date of Approval: 08/03/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Ivabradine in Prevention of POAF after CABG surgery
Official scientific title Efficacy of perioperative bisoprolol and ivabradine versus bisoprolol for prevention of atrial fibrillation after coronary artery bypass grafting
Brief summary describing the background and objectives of the trial Atrial fibrillation (AF) is the most common arrhythmia after cardiac surgery; it occurs in 5-40% of patients after coronary artery bypass grafting (CABG). Postoperative new onset AF is associated with increased risk of stroke, in-hospital and 6‐month mortality, and longer hospital stay, compared with populations with no new onset AF. The frequency of postoperative atrial fibrillation has increased over years despite recent developments in cardiac surgical techniques, anaesthetic management and myocardial protection. The exact mechanism underlying postoperative AF is still unclear. Evidence suggests initiation of AF by ectopic beats originating from the pulmonary veins. A recent study demonstrated that fast-pacemaker cardiomyocytes in the pulmonary veins have a larger Funny channels (If) current density than slow-pacemaker ones. Ivabradine (Procoralan®) reduces heart rate by selectively inhibiting If current in the sinoatrial node pacemaker cells, in a dose-dependent manner. This agent has been originally approved for treating stable coronary artery disease, left ventricular (LV) systolic dysfunction and chronic heart failure (HF), in which favorable clinical outcomes have been demonstrated. However, there is still ongoing controversy regarding the potential role of ivabradine might have on AF. The aim of this study is to evaluate the efficacy of the peri-operative use of bisoprolol and ivabradine versus bisoprolol in the prevention of post-operative atrial fibrillation in patients undergoing elective coronary artery bypass grafting surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/06/2020
Actual trial start date 01/06/2020
Anticipated date of last follow up 01/06/2021
Actual Last follow-up date 01/06/2021
Anticipated target sample size (number of participants) 50
Actual target sample size (number of participants) 50
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Ivabradine and bisoprolol Ivabradine (Procoralan®) at dose 5mg twice daily orally for the first 24 hours, then 7.5mg twice daily thereafter Bisoprolol (concor®) 5mg once daily 48 hours pre-operatively and continued one week post-operatively. patients will receive peri-operative ivabradine (Procoralan®) 48 hours before surgery and continued for one-week post-operative at dose 5mg twice daily orally for the first 24 hours, then 7.5 mg twice daily thereafter and bisoprolol (concor®) 5mg once daily starting 48 hours pre-operatively and continued one week post-operatively. 25
Control Group Bisoprolol alone Bisoprolol (concor®) 5mg once daily 48 hours pre-operatively and continued one week post-operatively. patients will receive peri-operative bisoprolol (concor®) 5mg once daily starting 48 hours pre-operatively and continued one week post-operatively. (12) 25 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients who will be scheduled for coronary artery bypass graft surgery (CABG). - Patients with atrial fibrillation or past history of atrial fibrillation. - Concurrent valve surgery or valvular heart diseases (including moderate to severe mitral or aortic regurgitation or stenosis). - Preoperative heart rate of < 50 beats/minute, 2nd or 3rd degrees AV block. - Prior coronary artery bypass graft. - Abnormal renal function with creatinine level (>2mg/dl), end stage renal disease (ESRD) on maintenance dialysis. - Patients on chronic amiodarone or digoxin therapy. - Poor left ventricular function (Ejection fraction < 35 %). - Emergency operation. Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 35 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/04/2020 Ethics Committee Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
Champollion Street, El-Khartoum Square, El Azareeta Medical Campus Alexandria 21131 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Atrial fibrillation Throughout the patient stay in the intensive care unit.
Secondary Outcome Heart rate Throughout the patient stay in the intensive care unit.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Department of Cardiothoracic Surgery in Alexandria Main University Hospital Champollion street Al Mesallah Sharq Al Attarin Alexandria Governorate Alexandria 21131 Egypt
International Cardiac Center at Alexandria. 24 Bahaa ElDin ElGhatwary Street Semouha Alexandria 21648 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed Mohamed Elsayed Elba Champollion street Al Mesallah Sharq Al Attarin Alexandria 21131 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Medicine University of Alexandria Faculty of Medicine Champollion Street, ElKhartoum Square ElAzareeta Medical Campus Alexandria 21131 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ahmed Mohamed Elsayed Elba Champollion street Al Mesallah Sharq Al Attarin Alexandria Governorate Alexandria 21131 Egypt
Amal Mohamed Sabry Ahmed Champollion street Al Mesallah Sharq Al Attarin Alexandria Governorate Alexandria 21131 Egypt
Ahmed Youssef Ali Champollion street Al Mesallah Sharq Al Attarin Alexandria Governorate Alexandria 21131 Egypt
Ayman Fathy Khalifa Champollion street Al Mesallah Sharq Al Attarin Alexandria Governorate Alexandria 21131 Egypt
Mohamed Khaled Elfeky Champollion street Al Mesallah Sharq Al Attarin Alexandria Governorate Alexandria 21131 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Amal Ahmed aml.ahmed@alexmed.edu.eg 00201005728066 Champollion street Al Mesallah Sharq Al Attarin Alexandria Governorate
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Professor of Anesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Ahmed Ali ahmed.mohmed@alexmed.edu.eg 00201222283266 Champollion street Al Mesallah Sharq Al Attarin Alexandria Governorate
City Postal code Country Position/Affiliation
Alexandria 21131 Egypt Professor of Anesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information