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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
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)
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)
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 moreSide effects data
From 2015 Phase 3 trial • 100 Patients • NCT019854256%
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
157 Previous Clinical Trials
686,447 Total Patients Enrolled
31 Trials studying Atrial Fibrillation
52,792 Patients Enrolled for Atrial Fibrillation
Alexander Benz, MDPrincipal InvestigatorPopulation Health Research Institute
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