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Colchicine for Atrial Fibrillation (PAPERS Trial)
Phase 2
Waitlist Available
Led By Parin J. Patel, MD
Research Sponsored by St. Vincent Cardiovascular Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
- All patients >/= 18 undergoing atrial fibrillation ablation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
PAPERS Trial Summary
This trial is looking at whether colchicine can reduce the incidence of pericarditis (inflammation of the lining around the heart) after atrial fibrillation ablation. They will compare patients who are on anti-inflammatories before the procedure and those who are not to see if there is a difference.
Eligible Conditions
- Atrial Fibrillation
- Pericarditis
- Catheter Ablation
PAPERS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowPAPERS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients with Pericarditis
Secondary outcome measures
Median rating of patient satisfaction on a Likert scale, comparing the study group and standard of care group.
Proportion of patients with recurrent Atrial fibrillation
Side effects data
From 2021 Phase 4 trial • 280 Patients • NCT017099811%
Chest pain
1%
Ischemic stroke
100%
80%
60%
40%
20%
0%
Study treatment Arm
Colchicine
Placebo
PAPERS Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ColchicineExperimental Treatment1 Intervention
0.6mg colchicine oral twice daily for 7 days.
Group II: Standard of careActive Control1 Intervention
Usual standard of care post atrial fibrillation ablation.
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?
St. Vincent Cardiovascular Research InstituteLead Sponsor
1 Previous Clinical Trials
160 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
160 Patients Enrolled for Atrial Fibrillation
Parin J. Patel, MDPrincipal InvestigatorPhysician; Board Member, Institutional Review Board; Board Member, Cardiovascular Research Institute
Frequently Asked Questions
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