Status:
COMPLETED
Post-Ablation Pericarditis Reduction Study
Lead Sponsor:
St. Vincent Cardiovascular Research Institute
Conditions:
Atrial Fibrillation
Catheter Ablation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
There has not been a prospective, randomized controlled trial of colchicine to reduce post-AF ablation pericarditis in an era of newer AF ablation techniques. The hypothesis is that an empiric pre and...
Detailed Description
This study will be a prospective, randomized controlled study of 248 patients presenting to the electrophysiology lab at Ascension St. Vincent (Indianapolis, IN) and Ascension Sacred Heart (Pensacola,...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- \- All patients \>/= 18 undergoing atrial fibrillation ablation
- Exclusion Criteria:
- Patients unable to receive or tolerate colchicine
- Pregnant or lactating women
- Concomitant use of drugs interacting with colchicine (including: cyclosporin, ranolazine, tacrolimus, clarithromycin, indinavir, itraconazole, ketoconazole, nefazadone, ritonavir, saquinavir, suboxone, telithromycin, erythromycin, fluconazole, verapamil, diltiazem, or more than 1 glass grapefruit juice daily)
- Severe renal impairment (CrCl \< 30 mL/min)
- Severe hepatic impairment (ALT/AST greater than 5x ULN or clinical cirrhosis)
- Ongoing current use of colchicine.
Exclusion
Key Trial Info
Start Date :
May 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2022
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT04906720
Start Date
May 20 2021
End Date
October 1 2022
Last Update
November 8 2022
Active Locations (1)
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1
Ascension St Vincent Hospital
Indianapolis, Indiana, United States, 46260