Use of Colchicine to Decrease Atrial Fibrillation Recurrence After Ablation

NCT05459974 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 00361
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

Ablation of atrial fibrillation (AFib) has been recommended as a therapeutic option when rhythm maintenance strategy is sought. One of the main objectives of an AFib ablation procedure is electrical isolation of the pulmonary veins, which have been identified as common triggering sites of the arrhythmia. The pathophysiology of AFib is not fully elucidated. Inflammation seems to play an important role in the initiation and maintenance of AFib. Previous studies have shown that inflammatory markers reactivity (eg, C-reactive protein \[CRP\] complex levels, elevation of white blood cells) are increased in patients who develop AFib. Similarly, recurrence of AFib within the first few weeks after ablation procedure seems to be mediated by an inflammatory process triggered by the ablation per se as implied by increased early CRP levels in AFib ablation patients. On the other hand, AFib can further induce and maintain a cascade of inflammatory events leading to electrical and structural atrial remodeling which leads to higher incidence of Afib development. Many trials have investigated the role of anti-inflammatory agents in preventing post-ablation AFib, using various treatment regimens such as corticosteroid therapy, antiarrhythmic medications like amiodarone, intravenous magnesium, atorvastatin, and colchicine. Previous studies have shown that colchicine can lead to decreased recurrence of post-ablation AFib with a beneficial impact in self-perceived quality of life of the patients. There is limited knowledge regarding the impact of colchicine duration and dosing on post-ablation Afib recurrence and the self-perceived quality of life. The information obtained from this study will ultimately guide future clinical practice to ensure safer outcomes.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Ablation outcomes; Atrial fibrillation recurrence; Quality of life

Outcome Measures

Primary Outcomes (3)

• Atrial fibrillation recurrence (Efficacy)

  To compare the time to first recurrence of atrial arrhythmias between the two groups, up to 12 months post AFib ablation.

  12 months

• Post-ablation quality of life

  To compare the quality of life between the two groups post AFib ablation using a validated questionnaire: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire. The score has 20 questions on a seven point Likert scale to evaluates health related quality of Life across three domains: Symptoms, Daily Activities function and Treatment concerns. It will be used to assess the change in the score before and after the intervention.

  at 12 months

• Post-ablation quality of life

  To compare the quality of life between the two groups post AFib ablation using a validated questionnaire: Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire. The score has 20 questions on a seven point Likert scale to evaluates health related quality of Life across three domains: Symptoms, Daily Activities function and Treatment concerns. It will be used to assess the change in the score before and after the intervention.

  at 1 month

Secondary Outcomes (6)

• Safety and Tolerability of Colchicine

  1 month

• Compliance of medication use

  1 month

• Atrial fibrillation burden

  12 months

• Procedure related outcomes

  12 months

• All-cause mortality outcomes

  12 months

Study Arms (2)

Colchicine arm

ACTIVE COMPARATOR

Drug: Colchicine 0.6 mg

Placebo arm

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Colchicine 0.6 mg DRUG

Colchicine 0.6 mg once daily for 30 days after the atrial fibrillation ablation

Colchicine arm

Placebo DRUG

Placebo pill once daily for 30 days after the atrial fibrillation ablation

Placebo arm

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
• Patients with paroxysmal or persistent atrial fibrillation scheduled to undergo index or repeat Afib ablation procedure (radiofrequency) and or cavotricuspid line ablation, other right/left atrial sites, left at discretion of treating physician.
• Ability of patient to provide informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

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

• Abhijeet Singh, MD

  abhijeet.singh@stonybrookmedicine.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammed Al-Sadawi, MBBCh

CONTACT

631-942-2101; mohammed.al-sadawi@stonybrookmedicine.edu

Faisal Aslam, MD

CONTACT

631-942-2566; faisal.aslam@stonybrookmedicine.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded randomized controlled trial
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 15, 2022
• Study Start: June 20, 2022
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2024
• Last Updated: July 15, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)