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NCT Number: NCT04160117

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

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Disease Attributes Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton Health Sciences Corporation - Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine 0.6 mg

Drug

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

Matching Placebo

Drug

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

Primary outcomes

  1. Average monthly enrollment rate

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

    Average number of patients enrolled per month

  2. Compliance with study treatment

    Time frame: From randomization until 10 days after catheter ablation

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

  3. Rate of complete follow-up at 6 months

    Time frame: From inception until completion of the study

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

Secondary outcomes

  1. Rate of non-infectious diarrhea

    Time frame: From randomization until 10 days after catheter ablation

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

  2. Rate of signs and symptoms of pericarditis

    Time frame: From randomization until 10 days after catheter ablation

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

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

    Time frame: From randomization until 2 weeks after catheter ablation for atrial fibrillation

    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

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

    Time frame: Between week 10 and 15 after catheter ablation for atrial fibrillation

    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

  5. Rate of patients with composite clinical endpoint

    Time frame: Through study completion (estimated to be up to 24 months)

    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

  6. Rate of all-cause mortality

    Time frame: Through study completion (estimated to be up to 24 months)

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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 12, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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