Phase 3 N=360 Randomized Prevention

Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients

Arrhythmia

Bottom Line

View on ClinicalTrials.gov: NCT03021343 ↗

Enrolled (actual)

360

Serious AEs

15.0%

Results posted

Dec 2017

Primary outcome: Primary: The Number of Participants With Atrial Fibrillation — 26; 37 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Colchicine (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Jordan Collaborating Cardiology Group
Primary completion: Jan 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Participants With Atrial Fibrillation	26; 37	—
PRIMARY The Number of Participants With Colchicine Side Effects	55; 14	—

Summary

This study evaluates the role of colchicine in the prevention of atrial fibrillation in patients undergoing open heart surgery. Half of participants will receive colchicine and the other half will not

Eligibility Criteria

Inclusion Criteria

All consecutive adult patients undergoing elective cardiac surgery

Exclusion Criteria

Documented history of AF or supraventricular arrhythmia or, absence of sinus rhythm on hospital admission
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
Significant gastrointestinal disease
Pregnant and lactating women
Known hypersensitivity to colchicine
Current treatment with colchicine for any indications
Emergency surgery

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03021343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.