Plain English Summary
Background and study aims
One of the most common complications suffered by patients following heart (cardiac) surgery is atrial fibrillation (AF). The heart consists of two upper chambers (atria) and two lower chambers (ventricles). Inside the right atrium, a cluster of cells (sinus node) are responsible for firing electrical signals into the heart muscle causing the heart to beat regularly (sinus rhythm). When a person is suffering from AF, the normal signals from the sinus node do not work properly, causing other parts of the atria to fire chaotically. These uncoordinated signals cause the heart to beat irregularly and often very fast (arrhythmia). Colchicine is a medication which is commonly used to treat inflammation (swelling) disorders such as gout (a type of arthritis). Recent studies have shown that it could also be used to prevent people from developing AF, although further research is needed to see how effective it is. The aim of this study is to find out whether treating patients with colchicine after cardiac surgery could help to prevent AF.
Who can participate?
Adults who are having heart surgery at a participating hospital.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group are given 2mg colchicine 12-24 hours before their surgery and another 1mg 4 hours before their surgery through a nasogastric tube (tube in the nose which leads straight to the stomach). The participants are given 0.5mg every day until they are discharged from hospital. Those in the second group receive normal care and are not given colchicine. Participants in both groups are attached to an ECG machine (heart scanner) so that any AF can be identified. Participants in the colchicine group are also interviewed and examined every day in order to find out if they are experiencing any side effects from the medication.
What are the possible benefits and risks of participating?
Participants who receive colchicine could be protected from AF and will have a smoother recovery period. Risks of taking part include side-effects of colchicine such as stomach upset and diarrhoea.
Where is the study run from?
Khalidi Hospital & Medical Center (lead centre) and four other hospitals in Jordan.
When is the study starting and how long is it expected to run for?
December 2012 to February 2015
Who is funding the study?
Jordan Collaborative Cardiology Group (Jordan)
Who is the main contact?
Dr Ramzi Tabbalat
Study website
Contact information
Type
Public
Contact name
Dr Ramzi Tabbalat
ORCID ID
http://orcid.org/0000-0003-2628-9618
Contact details
Khalidi Hospital and Medical Center
Iben Khaldoun Street
Amman
11185
Jordan
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
NCT03021343
Protocol/serial number
N/A
Study information
Scientific title
Effect of colchiciNe on the inciDence of Atrial Fibrillation in open heart surgery patients: The END-AF trial
Acronym
END-AF
Study hypothesis
The aim of this study is to determine if colchicine administered pre-operatively to patients undergoing cardiac surgery and continued during hospitalization is effective in reducing the incidence of postoperative AF.
Ethics approval(s)
1. Al Khalidi Ethical Research Board (ERB),10/10/2012
2. The Istishari Hospital Internal Review Board
3. Jordan Hospital Institutional Review Board/Ethics Committee, ref: JH IRB/EC
4. Ibn Al-Haytham Hospital Ethics Committee
Study design
Prospective randomized open-label multi-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet.
Condition
Atrial fibrillation post cardiac surgery
Intervention
Patients are randomized at least 12 to 24 hours prior to surgery to receive colchicine or no colchicine in an open label format. Randomization was performed by the principal investigator using an online Research Randomizer (www.randomizer.org).
Intervention group: Colchicine is administered at a dose of 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery (through a nasogastric tube) and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose is given to patients weighing <70 kg or intolerant to the full dose
Control group: Participants receive standard care with no administration of colchicine
Partcipants in both groups are continuously monitored using ECG to find the rate of AF. Participants in the intervention group are interviewed daily to evaluate side effects from colchicine administration.
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Phase IV
Drug/device/biological/vaccine name(s)
Colchicine
Primary outcome measure
1. Rate of AF is measured through continuous ECG monitoring until the time of discharge. Episodes of AF lasting for 5 minutes or more are continued significant and are recorded.
2. Occurrence of side effects is determined through daily patient examinations and patient interviews until the time of discharge
Secondary outcome measures
None
Overall study start date
16/10/2012
Overall study end date
03/02/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All adult patients undergoing elective cardiac surgery and cared for by participating cardiologists.
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
360
Total final enrolment
360
Participant exclusion criteria
1. Patients with a documented history of AF or supraventricular arrhythmia or, with absence of sinus rhythm on hospital admission
2. Known severe liver disease or current transaminases >1.5 times the upper normal limit
3. Current serum creatinine >2.5 mg/dl
4. Known myopathy or elevated baseline preoperative creatine kinase
5. Known blood dyscrasias
6. Significant gastrointestinal disease
7. Pregnant and lactating women
8. Known hypersensitivity to colchicine
9. Current treatment with colchicine for any indications
10. Emergency surgery
Recruitment start date
16/10/2012
Recruitment end date
26/01/2015
Locations
Countries of recruitment
Jordan
Study participating centre
Khalidi Hospital and Medical Center
Amman
11183
Jordan
Study participating centre
Istishari Hospital
Amman
11183
Jordan
Study participating centre
Jordan Hospital
Amman
1183
Jordan
Study participating centre
Islami Hospital
Amman
11165
Jordan
Study participating centre
Ibn Haytham Hospital
Amman
11181
Jordan
Sponsor information
Organisation
Jordan Collaborative Cardiology Group
Sponsor details
C/O Ayman Hammoudeh
MD
Istishari Hospital
44 Al Kindi St
Wadi Saqra
Amman
11184
Jordan
+962 6 5001000
hammoudeh_ayman@yahoo.com
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Jordan Collaborative Cardiology Group
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The results were presented as an abstract in the ESC meeting in London, 2015. The manuscript is to be submitted to the International Journal of Cardiology for publication.
Intention to publish date
30/06/2016
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2016 | 29/01/2019 | Yes | No |