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Impact of Short-course Colchicine Versus Placebo After Pulmonary Vein Isolation (IMPROVE-PVI Pilot)

Phase 3
Waitlist Available
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
All Individual Drugs Already Approved
Pivotal Trial
Approved for 5 Other Conditions

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
  • Relapse
  • 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Average monthly enrollment rate
Compliance with study treatment
Rate of complete follow-up at 6 months
Secondary study objectives
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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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
164 Previous Clinical Trials
718,312 Total Patients Enrolled
33 Trials studying Atrial Fibrillation
54,922 Patients Enrolled for Atrial Fibrillation
Alexander Benz, MDPrincipal InvestigatorPopulation Health Research Institute
~34 spots leftby Dec 2025
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