Trial Outcomes & Findings for Effect of Colchicine on the Incidence of Atrial Fibrillation in Open Heart Surgery Patients (NCT NCT03021343)

NCT ID: NCT03021343

Last Updated: 2018-01-23

Results Overview

The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 360 participants
• Primary outcome timeframe: From date of randomization until the date of discharge, assessed up to 2 weeks
• Results posted on: 2018-01-23

Participant Flow

Participant milestones

Measure	Colchicine Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose. Colchicine: colchicine given as per trial protocol	No Colchicine In this arm no active medication was administered
Overall Study STARTED	179	181
Overall Study COMPLETED	174	174
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Colchicine n=179 Participants Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose. Colchicine: colchicine given as per trial protocol	No Colchicine n=181 Participants In this arm no active medication was administered	Total n=360 Participants Total of all reporting groups
Age, Continuous	60.8 years n=179 Participants	60.5 years n=181 Participants	60.6 years n=360 Participants
Sex: Female, Male Female	38 Participants n=179 Participants	38 Participants n=181 Participants	76 Participants n=360 Participants
Sex: Female, Male Male	141 Participants n=179 Participants	143 Participants n=181 Participants	284 Participants n=360 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From date of randomization until the date of discharge, assessed up to 2 weeks

The primary efficacy end point was the rate of AF in both arms. AF lasting more than 5 minutes were considered significant

Outcome measures

Measure	Colchicine n=179 Participants Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose. Colchicine: colchicine given as per trial protocol	No Colchicine n=181 Participants In this arm no active medication was administered
The Number of Participants With Atrial Fibrillation	26 Participants	37 Participants

PRIMARY outcome

Timeframe: From date of randomization until the date of discharge, assessed up to 2 weeks

The primary safety endpoint was the occurrence of side effects. Side effects monitored were mainly gastrointestinal effects (especially diarrhoea), alopecia, anorexia, hepatotoxicity, myotoxicity, and bone marrow toxicity.

Outcome measures

Measure	Colchicine n=179 Participants Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose. Colchicine: colchicine given as per trial protocol	No Colchicine n=181 Participants In this arm no active medication was administered
The Number of Participants With Colchicine Side Effects	55 participants	14 participants

Adverse Events

Colchicine

Serious events: 44 serious events

Other events: 11 other events

Deaths: 0 deaths

No Colchicine

Serious events: 10 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Colchicine n=179 participants at risk Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose. Colchicine: colchicine given as per trial protocol	No Colchicine n=181 participants at risk In this arm no active medication was administered
Gastrointestinal disorders Diarrhea	24.6% 44/179 • Number of events 44	5.5% 10/181 • Number of events 10

Other adverse events

Measure	Colchicine n=179 participants at risk Colchicine 2 mg 12-24 hours prior to surgery and 1 mg 4 hours before or immediately after surgery and then continued at a dose of 0.5 mg twice daily until hospital discharge. Half the dose was given to patients weighing \<70 kg or intolerant to the full dose. Colchicine: colchicine given as per trial protocol	No Colchicine n=181 participants at risk In this arm no active medication was administered
Gastrointestinal disorders Anorexia	6.1% 11/179 • Number of events 11	2.2% 4/181 • Number of events 4

Additional Information

Dr. Ramzi Tabbalat

Khalidi Hospital & Medical Center

Phone: 00962795535522

Email: ramzi_md@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place