Effect of Low Dose ColchiciNe on the InciDence of POAF

Atrial Fibrillation Clinical Trial

— END-AFLD  

Official title:

Effect of Low Dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03015831
• Other study ID #: JordanCCG
• Status: Terminated
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Cardiac Surgery
• Colchicine Adverse Reaction

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