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END-AFLD: Effect of Low Dose ColchiciNe on the InciDence of POAF

Sponsor
Jordan Collaborating Cardiology Group (Other)
Overall Status
Terminated
CT.gov ID
NCT03015831
Collaborator
(none)
254
Enrollment
3
Locations
2
Arms
18.9
Actual Duration (Months)
84.7
Patients Per Site
4.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The prior End-AF study by the same group showed that 1 mg of colchicine didn't decrease the incidence of AF after cardiac surgery. The current study, End-AF Low Dose Study, will test 0.5 mg colchicine vs. placebo in preventing AF after cardiac surgery.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

AF after cardiac surgery leads to excess mortality and morbidity. Colchicine was used in several studies to lower the incidence AF but the results were generally disappointing. There was no benefit in reducing AF and there was a high incidence of GI side effects especially diarrhea, often leading to stopping the medication. However, a recently published meta-analysis showed that colchicine reduced AF, but again warned of the high incidence of GI side effects. The maintenance dose of colchicine used in these studies was 1 mg daily it is hypothesized that low dose colchicine (0.5 not 1 mg colchicine) might lower AF after cardiac surgery without the prohibitive GI side effects Patients will be randomized to colchicine vs. placebo started the day before surgery and continued until hospital discharge.

The primary efficacy endpoint will be the incidence of AF. The primary safety endpoint will be the GI side effects

Study Design

Study Type:
Interventional
Actual Enrollment :
254 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients
Actual Study Start Date :
Oct 2, 2017
Actual Primary Completion Date :
Apr 1, 2019
Actual Study Completion Date :
May 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Colchicine

Intervention by administering an active copmarator of 1 mg colchicine one day pre op and 0.5 mg daily after surgery until discharge

Drug: Colchicine
Colchicine will be given to open heart surgery patients
Other Names:
  • Colcrys, Mitigare

    		•
    Placebo Comparator: Placebo Oral Tablet

    Identical tablet (placebo) administered in a similar way as that in the active comparator arm

    Drug: Placebo Oral Tablet
    Placebo Oral Tablet will be given to open heart surgery patients according to randomization
    Other Names:
  • Placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Atrial fibrillation [Through study completion, an average of 1 week]

      AF documented by EKG

    Secondary Outcome Measures

    1. Side effects of colchicine [Through study completion, an average of 1 week]

      Gastrointestinal side effects

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • All patients aged 18 years or above undergoing elective cardiac surgery.

    • Sinus rhythm and no previous AF

    • Agreed to sign informed consent.

    Exclusion Criteria:

    • 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 or significant gastrointestinal disease

    • Pregnant and lactating women

    • Known hypersensitivity to colchicine

    • Current treatment with colchicine for any indications

    • Emergency surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Istishari Hospital Amman Jordan
    2 Jordan Hospital Amman Jordan
    3 Khalidi Hospital & Medical Center Amman Jordan

    Sponsors and Collaborators

    • Jordan Collaborating Cardiology Group

    Investigators

    • Principal Investigator: Ramzi Tabbalat, MD, FACC, JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jordan Collaborating Cardiology Group
    ClinicalTrials.gov Identifier:
    NCT03015831
    Other Study ID Numbers:
    • JordanCCG
    First Posted:
    Jan 10, 2017
    Last Update Posted:
    May 1, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jordan Collaborating Cardiology Group
    Atrial fibrillation
    Cardiac surgery
    Colchicine
    Additional relevant MeSH terms:
    Atrial Fibrillation
    Colchicine

    Study Results

    No Results Posted as of May 1, 2020