NCT03015831

Effect of Low Dose ColchiciNe on the InciDence of POAF

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Jordan Collaborating Cardiology Group · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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

Conditions

• Atrial Fibrillation
• Cardiac Surgery
• Colchicine Adverse Reaction

Interventions

Type	Name	Description
DRUG	Colchicine	Colchicine will be given to open heart surgery patients
DRUG	Placebo Oral Tablet	Placebo Oral Tablet will be given to open heart surgery patients according to randomization

Timeline

• Start date: 2017-10-02
• Primary completion: 2019-04-01
• Completion: 2019-05-01
• First posted: 2017-01-10
• Last updated: 2020-05-01

Locations

3 sites across 1 country: Jordan