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Colchicine 0.6 mg for Atrial Fibrillation

Phase 3
Recruiting
Led By Alexander Benz, MD
Research Sponsored by Population Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)
Awards & highlights

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
  • Atrial Fibrillation
  • Recurrence

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Average monthly enrollment rate
Compliance with study treatment
Rate of complete follow-up at 6 months
Secondary outcome measures
Rate of all-cause mortality
Rate of non-infectious diarrhea
Rate of patients with composite clinical endpoint
+3 more

Side effects data

From 2015 Phase 3 trial • 100 Patients • NCT01985425
6%
Acute Respiratory Distress Syndrome
4%
fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Colchicine
Placebo Colchicine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: InterventionExperimental Treatment1 Intervention
Colchicine 0.6 mg p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
Group II: ControlPlacebo Group1 Intervention
Matching placebo p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine
FDA approved

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor
155 Previous Clinical Trials
679,712 Total Patients Enrolled
30 Trials studying Atrial Fibrillation
52,102 Patients Enrolled for Atrial Fibrillation
Alexander Benz, MDPrincipal InvestigatorPopulation Health Research Institute

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the main goals that we are hoping to achieve with this experiment?

"The primary outcome of this study will be compliance with treatment, as assessed over a 24-month period (with an estimated 18-month enrollment phase). Secondary outcomes include the rate of signs and symptoms of pericarditis (defined as evidence of new or worsening pericardial effusion on echocardiogram, friction rub on auscultation, or pleuritic chest pain), recurrence of atrial fibrillation within 2 weeks after catheter ablation (defined as any episode of atrial fibrillation lasting more than 30 seconds within 2 weeks after ablation for atrial fibrillation, at"

Answered by AI

Why is Colchicine 0.6 mg often prescribed?

"gout flares is commonly treated with Colchicine 0.6 mg. Other conditions that can be treated by Colchicine 0.6 mg include behcet's syndrome, postcommissurotomy syndrome, and familial mediterranean fever."

Answered by AI

Can people still sign up for this research program?

"This clinical trial, which is currently recruiting patients, was originally posted on 1/14/2020 and was last updated on 9/19/2022."

Answered by AI

Just curious, how many people have signed up for this healthcare experiment?

"That is correct, the online information does show that the trial is open for recruitment. The listing was first posted on January 14th, 2020 and was most recently updated on September 19th, 2022. They are looking for a total of 200 people to participate at 1 site."

Answered by AI

What have been the most serious adverse effects of Colchicine 0.6 mg in clinical trials?

"Colchicine 0.6 mg is a Phase 3 trial drug, meaning that there is some efficacy data as well as multiple rounds of safety data, so we feel confident giving it a score of 3."

Answered by AI
~38 spots leftby Apr 2025