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

Primary Purpose

Arrhythmia

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Colchicine
Sponsored by
Jordan Collaborating Cardiology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arrhythmia focused on measuring Atrial fibrillation, Colchicine, Cardiac surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Colchicine

    No colchicine

    Arm Description

    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.

    In this arm no active medication was administered

    Outcomes

    Primary Outcome Measures

    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    December 22, 2015
    Last Updated
    December 24, 2017
    Sponsor
    Jordan Collaborating Cardiology Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03021343
    Brief Title
    Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients
    Acronym
    END-AF
    Official Title
    Effect of ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2012 (undefined)
    Primary Completion Date
    January 2015 (Actual)
    Study Completion Date
    February 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Jordan Collaborating Cardiology Group

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Arrhythmia
    Keywords
    Atrial fibrillation, Colchicine, Cardiac surgery

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    360 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Colchicine
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    No colchicine
    Arm Type
    No Intervention
    Arm Description
    In this arm no active medication was administered
    Intervention Type
    Drug
    Intervention Name(s)
    Colchicine
    Intervention Description
    colchicine given as per trial protocol
    Primary Outcome Measure Information:
    Title
    The Number of Participants With Atrial Fibrillation
    Description
    The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant
    Time Frame
    From date of randomization until the date of discharge, assessed up to 2 weeks
    Title
    The Number of Participants With Colchicine Side Effects
    Description
    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.
    Time Frame
    From date of randomization until the date of discharge, assessed up to 2 weeks

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ramzi A Tabbalat, MD, FACC
    Organizational Affiliation
    Khalidi Hospital and Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing 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
    Citations:
    PubMed Identifier
    27502857
    Citation
    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.
    Results Reference
    result

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

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