Colchicine After Electrocardioversion for Atrial Fibrillation
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >18 years
ECG-documented AF prior to ECV
Successful ECV with conversion of AF to sinus rhythm with persistent sinus rhythm ≥30 minutes after ECV
Ability to give written informed consent
Disqualifiers
AF persistence after cardioversion or early AF recurrence within 30 minutes 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
Trial design
Design model
Parallel
Treatments tested in this trial
Colchicine
DrugColchicine 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
DrugMatched placebo. Both the active drug and placebo will look similarly. The route and mode of administration is also similar to the active group.
Treatment groups
416 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
within 6 month after electrocardioversionSecondary outcomes
1
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.
Time frame
within 1 month after electrocardioversion2
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.
Time frame
within 3 month after electrocardioversion3
Time to first redo electrocardioversion
Time to first redo electrocardioversion
Time frame
up to 6 month4
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)
Time frame
within 6 month after electrocardioversionSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Basel, Switzerland
Lead sponsor
Swiss Heart Foundation
Collaborator
Fondation Machaon, Switzerland, Genf
Collaborator
Foundation for Cardiovascular Research Basel
Collaborator
Source ClinicalTrials.gov