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

NCT04160117 | Completed Phase 3 DMC

• 1 other identifier: IMPROVE-PVI pilot
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation; Recurrence

Outcome Measures

Primary Outcomes (3)

• 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)

• Compliance with study treatment

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

  From randomization until 10 days after catheter ablation

• 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 Outcomes (6)

• Rate of non-infectious diarrhea

  From randomization until 10 days after catheter ablation

• Rate of signs and symptoms of pericarditis

  From randomization until 10 days after catheter ablation

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

  From randomization until 2 weeks after catheter ablation for atrial fibrillation

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

  Between week 10 and 15 after catheter ablation for atrial fibrillation

• Rate of patients with composite clinical endpoint

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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Drug: Colchicine 0.6 mg

Control

PLACEBO COMPARATOR

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

Drug: Matching placebo

Interventions

Colchicine 0.6 mg DRUG

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

Intervention

Matching placebo DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (1)

Hamilton Health Sciences Corporation - Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

• Benz AP, Amit G, Connolly SJ, Singh J, Acosta-Velez JG, Conen D, Deif B, Divakaramenon S, McIntyre WF, Mtwesi V, Roberts JD, Wong JA, Zhao R, Healey JS; IMPROVE-PVI Investigators. Colchicine to Prevent Atrial Fibrillation Recurrence After Catheter Ablation: A Randomized, Placebo-Controlled Trial. Circ Arrhythm Electrophysiol. 2024 Jan;17(1):e01238. doi: 10.1161/CIRCEP.123.012387. Epub 2023 Dec 21.

  PMID: 38126206 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Recurrence

Interventions

Colchicine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Alexander Benz, MD

  Population Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: January 14, 2020
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)