Colchicine 0.6 mg for Relapse

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Relapse+1 More
Colchicine 0.6 mg - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial will study whether colchicine, a potent anti-inflammatory drug, can help improve patient outcomes after catheter ablation for atrial fibrillation.

Eligible Conditions
  • Relapse
  • Atrial Fibrillation

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

3 Primary · 6 Secondary · Reporting Duration: Through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)

Week 10
Recurrence of atrial fibrillation between 10-15 weeks after catheter ablation
From inception until completion of the study
Rate of complete follow-up at 6 months
Day 10
Compliance with study treatment
Rate of non-infectious diarrhea
Rate of signs and symptoms of pericarditis
Week 2
Recurrence of atrial fibrillation within the first 2 weeks after catheter ablation
Month 24
Average monthly enrollment rate
Month 24
Rate of all-cause mortality
Rate of patients with composite clinical endpoint

Trial Safety

Safety Progress

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

Side Effects for

Active Colchicine
6%Acute Respiratory Distress Syndrome
4%fall
This histogram enumerates side effects from a completed 2015 Phase 3 trial (NCT01985425) in the Active Colchicine ARM group. Side effects include: Acute Respiratory Distress Syndrome with 6%, fall with 4%.

Trial Design

2 Treatment Groups

Intervention
1 of 2
Control
1 of 2

Experimental Treatment

Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: Colchicine 0.6 mg · Has Placebo Group · Phase 3

Intervention
Drug
Experimental Group · 1 Intervention: Colchicine 0.6 mg · Intervention Types: Drug
Control
Drug
PlaceboComparator Group · 1 Intervention: Matching placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
142 Previous Clinical Trials
661,639 Total Patients Enrolled
Alexander Benz, MDPrincipal InvestigatorPopulation Health Research Institute

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 29th, 2021

Last Reviewed: November 14th, 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.