Clinical trial NCT03015831: Effect of Low Dose ColchiciNe on the InciDence of POAF
Official title: Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atrial Fibrillation
Cardiac Surgery
Colchicine Adverse Reaction
Keywords: Atrial fibrillation
Cardiac surgery
Colchicine
Lead sponsor: Jordan Collaborating Cardiology Group
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Atrial fibrillation
timeFrame: Through study completion, an average of 1 week
Secondary outcomes:
measure: Side effects of colchicine
timeFrame: Through study completion, an average of 1 week
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: Istishari Hospital
city: Amman
country: Jordan
facility: Jordan Hospital
city: Amman
country: Jordan
facility: Khalidi Hospital & Medical Center
Study officials:
affiliation: JCC Group, Cardiology Department, Khalidi Medical Center, Amman, Jordan
name: Ramzi Tabbalat, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tabbalat RA, Alhaddad I, Hammoudeh A, Khader YS, Khalaf HA, Obaidat M, Barakat J. Effect of Low-dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Low Dose Trial. J Int Med Res. 2020 Jul;48(7):300060520939832. doi: 10.1177/0300060520939832.