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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03015831
Other study ID # JordanCCG
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date October 2, 2017
Est. completion date May 1, 2019

Study information

Verified date April 2020
Source Jordan Collaborating Cardiology Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Terminated
Enrollment 254
Est. completion date May 1, 2019
Est. primary completion date April 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Study Design


Intervention

Drug:
Colchicine
Colchicine will be given to open heart surgery patients
Placebo Oral Tablet
Placebo Oral Tablet will be given to open heart surgery patients according to randomization

Locations

Country Name City State
Jordan Istishari Hospital Amman
Jordan Jordan Hospital Amman
Jordan Khalidi Hospital & Medical Center Amman

Sponsors (1)

Lead Sponsor Collaborator
Jordan Collaborating Cardiology Group

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Atrial fibrillation AF documented by EKG Through study completion, an average of 1 week
Secondary Side effects of colchicine Gastrointestinal side effects Through study completion, an average of 1 week
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