Colchicine After Electrocardioversion for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— COLECTRO-AF  

Official title:

Colchicine After Electrocardioversion for Atrial Fibrillation - The COLECTRO-AF Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05890664
• Other study ID #: 2023-00548, kt21sticherling
• Status: Recruiting
• Phase: Phase 3
• Start date: April 14, 2024
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: University Hospital, Basel, Switzerland
• Contact: Philipp Krisai, PD Dr. med.
• Phone: +41 61 265 25 25
• Email: Philipp.krisai[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 416
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Atrial Fibrillation
• Cardiac Arrhythmia

Intervention

Drug:
• Colchicine
Colchicine 0.5 mg (oral) once daily for 90 days. The chemical name for colchicine is (S)-N-(5,6,7,9-tetrahydro-1,2,3,10-tetramethoxy-9 oxobenzol[a]heptalen-7-yl) acetamide. Colchicine consists of pale yellow scales or powder. It is soluble in water, freely soluble in alcohol, and slightly soluble in ether.
• Placebo
Matched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel
Switzerland	University Hospital Bern	Bern
Switzerland	Solothurner Spitäler AG	Solothurn

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Fondation Machaon, Switzerland, Genf, Foundation for Cardiovascular Research Basel, Swiss Heart Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of atrial fibrillation (AF) recurrence	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.	within 6 month after electrocardioversion
Secondary	Number of atrial fibrillation (AF) recurrence	The secondary outcome of AF recurrence within 1 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.	within 1 month after electrocardioversion
Secondary	Number of atrial fibrillation (AF) recurrence	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.	within 3 month after electrocardioversion
Secondary	Time to first redo electrocardioversion	Time to first redo electrocardioversion	up to 6 month
Secondary	Use of antiarrhythmic drugs	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)	within 6 month after electrocardioversion
Secondary	Number of survived participants without an unplanned hospital stay	Number of survived participants without an unplanned hospital stay	up to 6 month