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

Primary Purpose

Atrial Fibrillation, Recurrence

Status

Recruiting

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Colchicine 0.6 mg

Matching placebo

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years
Symptomatic atrial fibrillation and planned catheter-guided first or repeat ablation (pulmonary vein isolation) for atrial fibrillation (radiofrequency or cryoablation energy; concomitant ablation of the cavotricuspid isthmus and other lesions left at the discretion of the treating physician)
Written informed consent

Exclusion Criteria:

Ablation for left atrial tachycardia or isthmus-dependent atrial flutter only (i.e. without pulmonary vein isolation)
Administration of a strong inhibitor of CYP3A4 or p-gp (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)
Known hypersensitivity to colchicine
Serious gastrointestinal disease (severe gastritis or diarrhea)
Clinically overt hepatic disease
Severe renal disease (eGFR< 30ml/min/1.73m2)
Clinically significant blood dyscrasia (e.g., myelodysplasia)
Absolute indication for or ongoing treatment with colchicine
Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control

Sites / Locations

Hamilton Health Sciences Corporation - Hamilton General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

Colchicine 0.6 mg p.o. twice daily for 10 days after catheter ablation for atrial fibrillation

Matching placebo p.o. twice daily for 10 days after catheter ablation for atrial fibrillation

Outcomes

Primary Outcome Measures

Average monthly enrollment rate

Average number of patients enrolled per month

Compliance with study treatment

Number of provided capsules taken (measured as a proportion of 20 capsules)

Rate of complete follow-up at 6 months

This will describe the rate of patients for whom the 6-month follow visit can be completed

Secondary Outcome Measures

Rate of non-infectious diarrhea

Three or more loose stools per day, in absence of an overt infectious cause

Rate of signs and symptoms of pericarditis

Evidence of new or worsening pericardial effusion on echocardiogram, friction rub on auscultation or pleuritic chest pain

Recurrence of atrial fibrillation within the first 2 weeks after catheter ablation

Any episode of atrial fibrillation lasting > 30 seconds within 2 weeks after catheter ablation for atrial fibrillation. Atrial flutter or other forms of atrial tachycardia are included in this definition

Recurrence of atrial fibrillation between 10-15 weeks after catheter ablation

Any episode of atrial fibrillation lasting > 30 seconds between 10-15 weeks after catheter ablation for atrial fibrillation. Atrial flutter or other forms of atrial tachycardia are included in this definition

Rate of patients with composite clinical endpoint

Emergency department visit: Patient seeking medical attention at any emergency department or Hospitalization for cardiovascular cause: Minimum of one overnight stay in hospital for cardiovascular reason (e.g. recurrence of atrial fibrillation, atrial flutter, atrial tachycardia; hypotension; hypertension; heart failure; myocardial infarction; bleeding, stroke etc.) or Cardioversion: Pharmacological or electrical attempt of or restoring sinus rhythm, irrespective of success of the procedure or Repeat ablation for atrial fibrillation, atrial flutter or left atrial tachycardia: Catheter-guided pulmonary vein isolation, or ablation of cavotricuspid isthmus, or ablation for other left atrial tachycardia (e.g. macro-reentrant tachycardia, focal tachycardia) after the index procedure

Rate of all-cause mortality

This will describe the rate of all-cause mortality during the course of the study.

Full Information

NCT ID

NCT04160117

First Posted

November 7, 2019

Last Updated

September 19, 2022

Sponsor

Population Health Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT04160117

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 14, 2020 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Population Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Recurrence is a common problem after catheter ablation for atrial fibrillation, affecting at least one out of three patients. Inflammation due to the procedure may contribute to pulmonary vein reconnection and, thus, failure of catheter ablation. This pilot study will assess whether a randomized, placebo-controlled, double-blind trial investigating a 10-day treatment with colchicine, a potent anti-inflammatory drug, to improve patient relevant outcomes after catheter ablation for atrial fibrillation is feasible.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Recurrence

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Colchicine 0.6 mg p.o. twice daily for 10 days after catheter ablation for atrial fibrillation

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Matching placebo p.o. twice daily for 10 days after catheter ablation for atrial fibrillation

Intervention Type

Drug

Intervention Name(s)

Colchicine 0.6 mg

Intervention Description

p.o. twice daily for 10 days after catheter ablation for atrial fibrillation

Intervention Type

Drug

Intervention Name(s)

Matching placebo

Intervention Description

p.o. twice daily for 10 days after catheter ablation for atrial fibrillation

Primary Outcome Measure Information:

Title

Average monthly enrollment rate

Description

Average number of patients enrolled per month

Time Frame

Through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)

Title

Compliance with study treatment

Description

Number of provided capsules taken (measured as a proportion of 20 capsules)

Time Frame

From randomization until 10 days after catheter ablation

Title

Rate of complete follow-up at 6 months

Description

This will describe the rate of patients for whom the 6-month follow visit can be completed

Time Frame

From inception until completion of the study

Secondary Outcome Measure Information:

Title

Rate of non-infectious diarrhea

Description

Three or more loose stools per day, in absence of an overt infectious cause

Time Frame

From randomization until 10 days after catheter ablation

Title

Rate of signs and symptoms of pericarditis

Description

Evidence of new or worsening pericardial effusion on echocardiogram, friction rub on auscultation or pleuritic chest pain

Time Frame

From randomization until 10 days after catheter ablation

Title

Recurrence of atrial fibrillation within the first 2 weeks after catheter ablation

Description

Time Frame

From randomization until 2 weeks after catheter ablation for atrial fibrillation

Title

Recurrence of atrial fibrillation between 10-15 weeks after catheter ablation

Description

Time Frame

Between week 10 and 15 after catheter ablation for atrial fibrillation

Title

Rate of patients with composite clinical endpoint

Description

Time Frame

Through study completion (estimated to be up to 24 months)

Title

Rate of all-cause mortality

Description

This will describe the rate of all-cause mortality during the course of the study.

Time Frame

Through study completion (estimated to be up to 24 months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years Symptomatic atrial fibrillation and planned catheter-guided first or repeat ablation (pulmonary vein isolation) for atrial fibrillation (radiofrequency or cryoablation energy; concomitant ablation of the cavotricuspid isthmus and other lesions left at the discretion of the treating physician) Written informed consent Exclusion Criteria: Ablation for left atrial tachycardia or isthmus-dependent atrial flutter only (i.e. without pulmonary vein isolation) Administration of a strong inhibitor of CYP3A4 or p-gp (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole) Known hypersensitivity to colchicine Serious gastrointestinal disease (severe gastritis or diarrhea) Clinically overt hepatic disease Severe renal disease (eGFR< 30ml/min/1.73m2) Clinically significant blood dyscrasia (e.g., myelodysplasia) Absolute indication for or ongoing treatment with colchicine Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Alex Benz

Phone

905-521-2100

IMPROVE-PVI@phri.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Alexander Benz, MD

Organizational Affiliation

Population Health Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton Health Sciences Corporation - Hamilton General Hospital

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Guy Amit, MD

Phone

905-527-1447

Ext

44760

amit@hhsc.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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