Colchicine for Atrial Fibrillation

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Atrial Fibrillation+2 More
Colchicine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess whether the administration of oral colchicine will reduce the incidence of perioperative atrial fibrillation in patients undergoing major thoracic surgery.

Eligible Conditions
  • Atrial Fibrillation
  • Atrial Flutter
  • Thoracic Surgery

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Atrial Fibrillation

Study Objectives

3 Primary · 12 Secondary · Reporting Duration: 14 days of randomization

14 days of randomization
All-cause mortality
Clinically important perioperative atrial fibrillation/atrial flutter
Duration of stay in ICU, step-down, and in-hospital
First occurrence of myocardial infarction
Myocardial Infarction
First occurrence of the composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke
Myocardial Reperfusion Injury
Life-threatening or major bleeding
Myocardial Reperfusion Injury
Non-infectious diarrhea
Number of days alive and at home
Occurrence of myocardial infarction
Occurrence of myocardial injury after noncardiac surgery
Communicable Diseases
Sepsis/infection
Time to chest tube removal
Day 14
Clinically important atrial fibrillation
Life-threatening bleeding
Hemorrhage
Myocardial infarction
Myocardial injury after noncardiac surgery (MINS)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Atrial Fibrillation

Side Effects for

Colchicine
1%Chest pain
1%Ischemic stroke
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT01709981) in the Colchicine ARM group. Side effects include: Chest pain with 1%, Ischemic stroke with 1%.

Trial Design

2 Treatment Groups

Colchicine
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group

3200 Total Participants · 2 Treatment Groups

Primary Treatment: Colchicine · Has Placebo Group · Phase 3

Colchicine
Drug
Experimental Group · 1 Intervention: Colchicine · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 days of randomization

Who is running the clinical trial?

Hamilton Health Sciences CorporationOTHER
341 Previous Clinical Trials
266,561 Total Patients Enrolled
10 Trials studying Atrial Fibrillation
6,236 Patients Enrolled for Atrial Fibrillation
Population Health Research InstituteLead Sponsor
141 Previous Clinical Trials
656,149 Total Patients Enrolled
26 Trials studying Atrial Fibrillation
42,671 Patients Enrolled for Atrial Fibrillation
David Conen, MD, MPHPrincipal InvestigatorPopulation Health Research Institute
1 Previous Clinical Trials
2,800 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
2,800 Patients Enrolled for Atrial Fibrillation
PJ Devereaux, MD, PhDStudy ChairPopulation Health Research Institute
6 Previous Clinical Trials
22,912 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
2,800 Patients Enrolled for Atrial Fibrillation

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are expected to require at least an overnight hospital admission after surgery.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 15th, 2021

Last Reviewed: October 8th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.