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.: PACTR202101651961317 Date of Approval: 21/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Prophylactic effect of colchincine and amiodarone
Official scientific title Prophylactic Effect of colchincine and amiodarone on occurrence of postoperative Atrial fibrillation after coronary artery bypass Graft surgery
Brief summary describing the background and objectives of the trial AF is one of the most common arrhythmic complication in patients undergoing coronary artery bypass grafting (CABG) as it incidence varies from 25.6% to 31% primarily within 2 to3days. .Amiodarone has been widely used for clinical purposes. Despite its antiarrhythmic characteristic, the use of this drug as a prophylactic agent against the occurrence of postoperative AF is uncommon and yet the use of amiodarone as prophylaxis in patients undergoing CABG is not routine. On the other hand, the role of amiodarone in reducing the post-CABG AF is controversial. Although preliminary data from using colchicine for prevention of the post pericardiotomy syndrome and postoperative atrial fibrillation (COPPS) trial for 1-month postoperative treatment with colchicine were promising. But there is a limitation of the COPPS trial was that colchicine was begun on postoperative day 3. Its beneficial effect may be further optimized when colchicine is started before surgery. So objective of this study is to investigate the effect of amiodarone and colchicine in reduction of post-CABG atrial fibrillation.
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 01/12/2019
Actual trial start date 01/12/2019
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date 28/02/2022
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants) 225
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Controlled group Patients who will receive only placebo (Controlled group) 6 preoperative and 6 days postoperative paracetmol tablet 75 Placebo
Experimental Group Colchincine group Patients who will receive prophylactic oral dose of colchicines night before and on day surgery and 0.5mg twice daily for 5 days postoperative Oral colchincine 75
Experimental Group Amiodarone group Patients who will receive prophylactic oral dose of amiodarone 5 mg/kg /day for 6 days before operation and 6 days after operation Oral amiodarone 75
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• Patients undergoing elective coronary artery bypass surgery • Emergency CABG. • Patients with chronic renal failure as diagnosed by serum creatinine level above 200μmol/l. • Patient undergoing CABG combined with valve surgery. • Patients undergoing Re-Do CABG. • Patients with history of atrial fibrillation determined by previous records. • Patients with known hypersensitivity-allergy to colchicine or amiodarone. • Under chronic treatment with colchicine or amiodarone. 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 18/11/2019 Tanta university faculty of medicine
Ethics Committee Address
Street address City Postal code Country
El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate Tanta 31527 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome evaluation preventive role of colchicine and amiodarone against atrial fibrillation after coronary artery bypass grafting. for 6 postoperative days
Secondary Outcome effect on Intensive care stay and hospital stay until discharge
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tanta university El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate Tanta 040 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Ali mahmoud Ahmed El-Gharbia Govenorate,Tanta . El-Gash st. Tanta 31527 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Tanta university El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate Tanta 31527 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Alaa basionuni El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate Tanta 31527 Egypt
Ayman sallam El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate Tanta 31527 Egypt
Amr abdelwhab El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate Tanta 31527 Egypt
Ahmed Emad El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate Tanta 31527 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Ahmed Betroa90@gmail.com 00201154629030 El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate
City Postal code Country Position/Affiliation
Tanta 21527 Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Alaa Basiony Alaabasionuni@yahoo.com 00201011323710 El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of cardiothoracic
Role Name Email Phone Street address
Scientific Enquiries Ahmed Emad Ahmed.ghoneim@med.tanta.edu.eg 00201173337000 El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Lecturer
Role Name Email Phone Street address
Public Enquiries Ayman Sallam Ayman_sal@hotmail.com 00201098121122 El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Professor of cardiothoracic
Role Name Email Phone Street address
Scientific Enquiries Amr Abdelwahab Amr.abdelwahab@med.tanta.edu.com 00201006632652 El-Gaish, Tanta Qism 2, Tanta, Gharbia Governorate
City Postal code Country Position/Affiliation
Tanta 31527 Egypt Assistant professor of cardiothoracic
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data will be available All individual participant data collected during trial after deidentification will be shared Data will be with anyone who wishes acess to the data Type of analysis to achieve approved proposal Study Protocol Immediately following publication no end date Prophylactic effect of colchincine and amiodarone
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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