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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04160117
• Other study ID #: IMPROVE-PVI pilot
• Status: Recruiting
• Phase: Phase 3
• Start date: January 14, 2020
• Est. completion date: January 2023

Study information

• Verified date: September 2022
• Source: Population Health Research Institute
• Contact: Alex Benz
• Phone: 905-521-2100
• Email: IMPROVE-PVI[@]phri.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years

2. 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)

3. Written informed consent

Exclusion Criteria:

1. Ablation for left atrial tachycardia or isthmus-dependent atrial flutter only (i.e. without pulmonary vein isolation)

2. Administration of a strong inhibitor of CYP3A4 or p-gp (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)

3. Known hypersensitivity to colchicine

4. Serious gastrointestinal disease (severe gastritis or diarrhea)

5. Clinically overt hepatic disease

6. Severe renal disease (eGFR< 30ml/min/1.73m2)

7. Clinically significant blood dyscrasia (e.g., myelodysplasia)

8. Absolute indication for or ongoing treatment with colchicine

9. Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control

Related Conditions & MeSH terms

• Atrial Fibrillation
• Recurrence

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences Corporation - Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average monthly enrollment rate	Average number of patients enrolled per month	Through study completion (enrollment phase estimated to last 18 months, total study duration estimated to last 24 months)
Primary	Compliance with study treatment	Number of provided capsules taken (measured as a proportion of 20 capsules)	From randomization until 10 days after catheter ablation
Primary	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	From inception until completion of the study
Secondary	Rate of non-infectious diarrhea	Three or more loose stools per day, in absence of an overt infectious cause	From randomization until 10 days after catheter ablation
Secondary	Rate of signs and symptoms of pericarditis	Evidence of new or worsening pericardial effusion on echocardiogram, friction rub on auscultation or pleuritic chest pain	From randomization until 10 days after catheter ablation
Secondary	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	From randomization until 2 weeks after catheter ablation for atrial fibrillation
Secondary	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	Between week 10 and 15 after catheter ablation for atrial fibrillation
Secondary	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	Through study completion (estimated to be up to 24 months)
Secondary	Rate of all-cause mortality	This will describe the rate of all-cause mortality during the course of the study.	Through study completion (estimated to be up to 24 months)