Colchicine After Electrocardioversion for Atrial Fibrillation

Phase 3

Recruiting

• Conditions: Atrial Fibrillation; Cardiac Arrhythmia
• Interventions: Drug: Placebo; Drug: Colchicine

• Registration Number: NCT05890664
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

The purpose of this study is to investigate whether a 3 month treatment course of low-dose Colchicine decreases the recurrence of Atrial fibrillation (AF) after electrocardioversion (ECV) in patients with AF.

Detailed Description

Atrial fibrillation is the most common cardiac arrhythmia worldwide and is associated with an increased risk of heart failure, stroke and death. Over the next 40 years the investigators expect another increase in the prevalence of atrial fibrillation with a risk of 1:3 in people over 65 years to develop atrial fibrillation. Electroconversion can occur in patients with atrial fibrillation reestablish sinus rhythm acutely with a controlled electrical shock. Unfortunately it is known however, that there is a short-term recurrence of atrial fibrillation in about 60%. This underlines that our current treatment options are inadequate. There is increasing evidence that inflammation is integral to initiation and maintenance of atrial fibrillation. Therefore, the researchers see inflammation as a possible therapeutic target to reduce the recurrence rate of atrial fibrillation after electroconversion. To test this hypothesis and to help patients, the investigators want to conduct the COLECTRO-AF study.

Study Timeline

• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-06-05
• Study First Posted: 2023-06-06
• Status Verified: 2024-04
• Study Start: 2024-04-14
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 416

Inclusion Criteria

• Age >18 years
• ECG-documented AF prior to ECV
• Successful ECV with conversion of AF to sinus rhythm with persistent sinus rhythm ≥1 hour after ECV
• Ability to give written informed consent

Exclusion Criteria

• AF persistence after cardioversion or early AF recurrence within 1 hour after ECV
• Any other rhythm than AF before cardioversion
• Pulmonary vein isolation within 3 months prior to ECV or pulmonary vein isolation planned within 3 months after ECV
• Known intolerance or hypersensitivity to Colchicine
• Any other absolute indication for Colchicine intake
• Intake of a strong inhibitor of CYP3A4 or P-Glycoprotein (clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole)
• 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)
• Significant immunosuppression (e.g. due to transplantation or rheumatic disease)
• Pregnant or breastfeeding women, or women of child-bearing potential who do not use a highly effective form of birth control
• Life expectancy <1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Placebo	Study participants in the placebo group will receive a matched placebo.
Experimental Group	Colchicine	Study participants in the active study arm will receive a daily oral dose of 0.5 mg Colchicine for 3 months without a loading dose. The dose is recommended to be taken in the morning. There is no deviation from the usual treatment intake.

Primary Outcome Measures

Name	Time	Method
Number of atrial fibrillation (AF) recurrence	within 6 month after electrocardioversion	The primary outcome of AF recurrence within 6 months will be assessed based on the ECG (electrocardiogram) documentation of any AF. If a patient reports symptoms of AF recurrence in between the study visits, the research staff will obtain an ECG documentation. The outcome will only be valid if AF recurrence is documented by an ECG.

Secondary Outcome Measures

Name	Time	Method
Number of survived participants without an unplanned hospital stay	up to 6 month	Number of survived participants without an unplanned hospital stay
Number of atrial fibrillation (AF) recurrence	within 3 month after electrocardioversion	The secondary outcome of AF recurrence within 3 months will be assessed based on the ECG (electrocardiogram) documentation of any AF. If a patient reports symptoms of AF recurrence in between the study visits, the research staff will obtain an ECG documentation. The outcome will only be valid if AF recurrence is documented by an ECG.
Time to first redo electrocardioversion	up to 6 month	Time to first redo electrocardioversion
Use of antiarrhythmic drugs	within 6 month after electrocardioversion	Assessment of medication intake by study staff Vaughan-Williams classification class 1 and 3 of antiarrhythmic drugs will be documented (1 = sodium channel blockade, 3 = potassium channel blockade)

Trial Locations

Locations (4)

Cantonal Hospital Baselland (KSBL); 🇨🇭 Bruderholz, Baselland, Switzerland

University Hospital Basel; 🇨🇭 Basel, Switzerland

University Hospital Bern; 🇨🇭 Bern, Switzerland

Solothurner Spitäler AG; 🇨🇭 Solothurn, Switzerland