Post-Ablation Pericarditis Reduction Study (PAPERS)

NCT06731595 | Completed Phase 2 FDA Drug

• 1 other identifier: PAPERS
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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 post AF ablation treatment protocol with colchicine may reduce the incidence and symptom severity of post-AF ablation related pericarditis. Thus, the goal of this study is to

1. 1.Identify the incidence of post-AF ablation related pericarditis in patients undergoing ablation via high power, short duration strategy (shorter total RF time, but increased stability due to steerable catheters and possible difference from resistive vs conductive heating).
2. 2.Identify potential differences in patients undergoing PVI only versus PVI + additional ablation
3. 3.Identify whether patients on who are already on anti-inflammatories such as ASA or statins have a lower incidence than those without
4. 4.Determine if an empiric treatment strategy with colchicine (for 7 days post ablation) reduces the incidence of post-operative AF

Conditions

Atrial Fibrillation; Catheter Ablation; Pericarditis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with Pericarditis

  Clinical pericarditis ascertained by comprehensive chart review and a follow up phone call using a survey instrument.

  Postoperative day 30.

Secondary Outcomes (2)

• Proportion of patients with recurrent Atrial fibrillation

  Through study completion, an average of 1 year

• Median rating of patient satisfaction on a Likert scale, comparing the study group and standard of care group.

  Postoperative day 14

Study Arms (2)

Standard of care

NO INTERVENTION

Usual standard of care post atrial fibrillation ablation.

Colchicine

EXPERIMENTAL

0.6mg colchicine oral twice daily for 7 days.

Drug: Colchicine

Interventions

Colchicine DRUG

colchicine 0.6mg oral twice daily for 7 days

Also known as: colcrys, mitigare

Colchicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients \>/= 18 undergoing atrial fibrillation ablation

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Vincent Cardiovascular Research Institute: lead
• Asenson Sacred Heart - Pensacoloa, FL: collaborator

Study Sites (1)

Ascension St Vincent Hospital

Indianapolis, Indiana, 46260, United States

Location

Related Publications (9)

• Leung YY, Yao Hui LL, Kraus VB. Colchicine--Update on mechanisms of action and therapeutic uses. Semin Arthritis Rheum. 2015 Dec;45(3):341-50. doi: 10.1016/j.semarthrit.2015.06.013. Epub 2015 Jun 26.

  PMID: 26228647 RESULT

• Imazio M, Bobbio M, Cecchi E, Demarie D, Demichelis B, Pomari F, Moratti M, Gaschino G, Giammaria M, Ghisio A, Belli R, Trinchero R. Colchicine in addition to conventional therapy for acute pericarditis: results of the COlchicine for acute PEricarditis (COPE) trial. Circulation. 2005 Sep 27;112(13):2012-6. doi: 10.1161/CIRCULATIONAHA.105.542738.

  PMID: 16186437 RESULT

• Imazio M, Brucato A, Ferrazzi P, Pullara A, Adler Y, Barosi A, Caforio AL, Cemin R, Chirillo F, Comoglio C, Cugola D, Cumetti D, Dyrda O, Ferrua S, Finkelstein Y, Flocco R, Gandino A, Hoit B, Innocente F, Maestroni S, Musumeci F, Oh J, Pergolini A, Polizzi V, Ristic A, Simon C, Spodick DH, Tarzia V, Trimboli S, Valenti A, Belli R, Gaita F; COPPS-2 Investigators. Colchicine for prevention of postpericardiotomy syndrome and postoperative atrial fibrillation: the COPPS-2 randomized clinical trial. JAMA. 2014 Sep 10;312(10):1016-23. doi: 10.1001/jama.2014.11026.

  PMID: 25172965 RESULT

• Tabbalat RA, Alhaddad I, Hammoudeh A, Khader YS, Khalaf HA, Obaidat M, Barakat J. Effect of Low-dose ColchiciNe on the InciDence of Atrial Fibrillation in Open Heart Surgery Patients: END-AF Low Dose Trial. J Int Med Res. 2020 Jul;48(7):300060520939832. doi: 10.1177/0300060520939832.

  PMID: 32720823 RESULT

• Deftereos S, Giannopoulos G, Kossyvakis C, Efremidis M, Panagopoulou V, Kaoukis A, Raisakis K, Bouras G, Angelidis C, Theodorakis A, Driva M, Doudoumis K, Pyrgakis V, Stefanadis C. Colchicine for prevention of early atrial fibrillation recurrence after pulmonary vein isolation: a randomized controlled study. J Am Coll Cardiol. 2012 Oct 30;60(18):1790-6. doi: 10.1016/j.jacc.2012.07.031. Epub 2012 Oct 3.

  PMID: 23040570 RESULT

• Deftereos S, Giannopoulos G, Efremidis M, Kossyvakis C, Katsivas A, Panagopoulou V, Papadimitriou C, Karageorgiou S, Doudoumis K, Raisakis K, Kaoukis A, Alexopoulos D, Manolis AS, Stefanadis C, Cleman MW. Colchicine for prevention of atrial fibrillation recurrence after pulmonary vein isolation: mid-term efficacy and effect on quality of life. Heart Rhythm. 2014 Apr;11(4):620-8. doi: 10.1016/j.hrthm.2014.02.002. Epub 2014 Feb 4.

  PMID: 24508207 RESULT

• Deyell MW, Leather RA, Macle L, Forman J, Khairy P, Zhang R, Ding L, Chakrabarti S, Yeung-Lai-Wah JA, Lane C, Novak PG, Sterns LD, Bennett MT, Laksman ZW, Sikkel MB, Andrade JG. Efficacy and Safety of Same-Day Discharge for Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2020 Jun;6(6):609-619. doi: 10.1016/j.jacep.2020.02.009. Epub 2020 Apr 29.

  PMID: 32553209 RESULT

• Ahmed AS, Clark BA, Joshi SA, Nair GV, Olson JA, Padanilam BJ, Patel PJ. Avoiding Bladder Catheters During Atrial Fibrillation Ablation. JACC Clin Electrophysiol. 2020 Feb;6(2):185-190. doi: 10.1016/j.jacep.2019.10.003. Epub 2019 Nov 27.

  PMID: 32081221 RESULT

• Gilge JL, Ahmed A, Clark BA, Slaten A, Devathu R, Olson JA, Padanilam BJ, Nair GV, Joshi SA, Ravichandran AK, Patel PJ. Left atrial hypertension and the risk of early incident heart failure after atrial fibrillation ablation. J Cardiovasc Electrophysiol. 2021 Feb;32(2):325-332. doi: 10.1111/jce.14829. Epub 2020 Dec 14.

  PMID: 33270311 RESULT

MeSH Terms

Conditions

Atrial Fibrillation; Pericarditis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Parin J. Patel, MD

  Physician; Board Member, Institutional Review Board; Board Member, Cardiovascular Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: May 20, 2021
• Primary Completion: January 30, 2022
• Study Completion: October 1, 2022
• Last Updated: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)