Effect of colchicine, an anti-inflammatory drug, on the chance of developing atrial fibrillation, a fast irregular heart beat, in open heart surgery patients

ISRCTN ISRCTN15501019
DOI https://doi.org/10.1186/ISRCTN15501019
ClinicalTrials.gov number NCT03021343
Secondary identifying numbers N/A
Submission date
27/12/2015
Registration date
31/12/2015
Last edited
03/08/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Ramzi Tabbalat
Public

Khalidi Hospital and Medical Center
Iben Khaldoun Street
Amman
11185
Jordan

ORCiD logoORCID ID 0000-0003-2628-9618

Study information

Study designProspective randomized open-label multi-centre trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleEffect of colchiciNe on the inciDence of Atrial Fibrillation in open heart surgery patients: The END-AF trial
Study acronymEND-AF
Study objectivesThe 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
Health condition(s) or problem(s) studiedAtrial fibrillation post cardiac surgery
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhasePhase IV
Drug / device / biological / vaccine name(s)Colchicine
Primary outcome measure1. 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 measuresNone
Overall study start date16/10/2012
Completion date03/02/2015

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants360
Total final enrolment360
Key inclusion criteriaAll adult patients undergoing elective cardiac surgery and cared for by participating cardiologists.
Key exclusion criteria1. 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
Date of first enrolment16/10/2012
Date of final enrolment26/01/2015

Locations

Countries of recruitment

  • Jordan

Study participating centres

Khalidi Hospital and Medical Center
Amman
11183
Jordan
Istishari Hospital
Amman
11183
Jordan
Jordan Hospital
Amman
1183
Jordan
Islami Hospital
Amman
11165
Jordan
Ibn Haytham Hospital
Amman
11181
Jordan

Sponsor information

Jordan Collaborative Cardiology Group
Research organisation

C/O Ayman Hammoudeh, MD
Istishari Hospital
44 Al Kindi St, Wadi Saqra
Amman
11184
Jordan

Phone +962 6 5001000
Email hammoudeh_ayman@yahoo.com

Funders

Funder type

Research organisation

Jordan Collaborative Cardiology Group

No information available

Results and Publications

Intention to publish date30/06/2016
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe 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.
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2016 29/01/2019 Yes No

Editorial Notes

03/08/2020: The following changes have been made:
1. The total final enrolment number has been added.
2. The ClinicalTrials.gov number has been added.
29/01/2019: Publication reference added