Effect of Low Dose ColchiciNe on the InciDence of POAF

Last updated: April 29, 2020
Sponsor: Jordan Collaborating Cardiology Group
Overall Status: Terminated

Phase

3

Condition

Chest Pain

Cardiac Surgery

Atrial Fibrillation

Treatment

N/A

Clinical Study ID

NCT03015831
JordanCCG
  • Ages 18-99
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 254
Study Start date:
October 02, 2017
Estimated Completion Date:
May 01, 2019

Study 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

Connect with a study center

  • Istishari Hospital

    Amman,
    Jordan

    Site Not Available

  • Jordan Hospital

    Amman,
    Jordan

    Site Not Available

  • Khalidi Hospital & Medical Center

    Amman,
    Jordan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.