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

• Register: ISRCTN
• Last refreshed on: 17 August 2020
• Main ID: ISRCTN15501019
• Date of registration: 31/12/2015
• Prospective Registration: No
• Primary sponsor: Jordan Collaborative Cardiology Group
• Public title: Effect of colchicine, an anti-inflammatory drug, on the chance of developing atrial fibrillation, a fast irregular heart beat, in open heart surgery patients
• Scientific title: Effect of colchiciNe on the inciDence of Atrial Fibrillation in open heart surgery patients: The END-AF trial
• Date of first enrolment: 16/10/2012
• Target sample size: 360
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN15501019
• Study type: Interventional
• Study design: Prospective randomized open-label multi-centre trial (Prevention)
• Phase: Phase IV

Countries of recruitment

Jordan

Contacts

• Name: Ramzi Tabbalat

Key inclusion & exclusion criteria

Inclusion criteria: All adult patients undergoing elective cardiac surgery and cared for by participating cardiologists.
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Atrial fibrillation post cardiac surgery
Circulatory System
Atrial fibrillation post cardiac surgery

Intervention(s)

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.

Primary Outcome(s)

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 ID(s)

NCT03021343

N/A

Source(s) of Monetary Support

Jordan Collaborative Cardiology Group

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 03/02/2015