Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients (END-AF)

December 24, 2017 updated by: Jordan Collaborating Cardiology Group

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

360

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Colchicine
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
colchicine given as per trial protocol
No Intervention: No colchicine
In this arm no active medication was administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Participants With Atrial Fibrillation
Time Frame: From date of randomization until the date of discharge, assessed up to 2 weeks
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
Time Frame: From date of randomization until the date of discharge, assessed up to 2 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordan Collaborating Cardiology Group

Investigators

  • Principal Investigator: Ramzi A Tabbalat, MD, FACC, Khalidi Hospital and Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

December 22, 2015

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

December 24, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KMC-JCC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

yes

IPD Sharing Time Frame

2 years from publication date

IPD Sharing Access Criteria

For research purposes after direct contact with principal investigator

IPD Sharing Supporting Information Type

  • Study Protocol

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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