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

NCT03021343 | Completed Phase 3 Results DMC

• 1 other identifier: KMC-JCC
• Study Type: interventional
• Target: 360
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Arrhythmia

Keywords

Atrial fibrillation; Colchicine; Cardiac surgery

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Colchicine

ACTIVE COMPARATOR

Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose.

Drug: Colchicine

No colchicine

NO INTERVENTION

In this arm no active medication was administered

Interventions

Colchicine DRUG

colchicine given as per trial protocol

Colchicine

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All consecutive adult patients undergoing elective cardiac surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Jordan Collaborating Cardiology Group: lead

Related 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 17.

  PMID: 27502857 RESULT

MeSH Terms

Conditions

Arrhythmias, Cardiac; Atrial Fibrillation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Ramzi Tabbalat
• Organization: Khalidi Hospital & Medical Center

ramzi_md@yahoo.com

00962795535522

Study Officials

• Ramzi A Tabbalat, MD, FACC

  Khalidi Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: January 13, 2017
• Study Start: October 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: January 23, 2018
• Results First Posted: December 26, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 2 years from publication date
• Access Criteria: For research purposes after direct contact with principal investigator