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Completed

NCT Number: NCT03021343

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

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

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine

Drug

colchicine given as per trial protocol

Primary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Jordan Collaborating Cardiology Group

Other

Registry information

Official study title

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

Acronym: END-AF

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 13, 2017
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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