Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients

Arrhythmia Clinical Trial

— END-AF  

Official title:

Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021343
• Other study ID #: KMC-JCC
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2015
• Last updated: December 24, 2017
• Start date: October 2012
• Est. completion date: February 2015

Study information

• Verified date: December 2017
• Source: Jordan Collaborating Cardiology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not

Description:

Atrial fibrillation (AF) is the most common arrhythmia in patients undergoing cardiac surgery and is estimated to occur in 26% of all cardiac surgery patients. It can lead to increase morbidity, mainly due to hemodynamic instability and thromboembolic complications, and to increased hospital stay with its associated higher health care cost.

Previous studies have demonstrated that increased inflammation may precede AF and, therefore, interventions that reduce the inflammatory process may help reduce the incidence of AF. Colchicine has potent anti-inflammatory properties and may therefore be capable of reducing the incidence of AF.

This study aims to determine whether the administration of colchicine starting the day before cardiac surgery and continuing until discharge may lead to reduction in post-operative AF.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All consecutive adult patients undergoing elective cardiac surgery

Exclusion Criteria:

• Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on hospital admission

• Known severe liver disease or current transaminases >1.5 times the upper normal limit

• Current serum creatinine >2.5 mg/dl

• Known myopathy or elevated baseline preoperative creatine kinase

• Known blood dyscrasias

• Significant gastrointestinal disease

• Pregnant and lactating women

• Known hypersensitivity to colchicine

• Current treatment with colchicine for any indications

• Emergency surgery

Related Conditions & MeSH terms

• Arrhythmia
• Atrial Fibrillation

Intervention

Drug:
• Colchicine
colchicine given as per trial protocol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Jordan Collaborating Cardiology Group

References & Publications (1)

Tabbalat RA, Hamad NM, Alhaddad IA, Hammoudeh A, Akasheh BF, Khader Y. Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial. Am Heart J. 2016 Aug;178:102-7. doi: 10.1016/j.ahj.2016.05.006. Epub 2016 May — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Participants With Atrial Fibrillation	The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant	From date of randomization until the date of discharge, assessed up to 2 weeks
Primary	The Number of Participants With Colchicine Side Effects	The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.	From date of randomization until the date of discharge, assessed up to 2 weeks