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Recruiting NCT05890664

Colchicine After Electrocardioversion for Atrial Fibrillation

Phase III Interventional Atrial Fibrillation Cardiac Arrhythmia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colchicine, Placebo.
Who it may be relevant to
Registry conditions: Atrial Fibrillation, Cardiac Arrhythmia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.
  • Drug 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.

Primary outcome measures

  • Number of atrial fibrillation (AF) recurrence [Time frame: within 6 month after electrocardioversion]
Secondary outcome measures (5)
  • Number of atrial fibrillation (AF) recurrence [Time frame: within 1 month after electrocardioversion]
  • Number of atrial fibrillation (AF) recurrence [Time frame: within 3 month after electrocardioversion]
  • Time to first redo electrocardioversion [Time frame: up to 6 month]
  • Use of antiarrhythmic drugs [Time frame: within 6 month after electrocardioversion]
  • Number of survived participants without an unplanned hospital stay [Time frame: up to 6 month]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Switzerland · 8 centers
  • Cantonal Hospital Baselland (KSBL) — Bruderholz
  • University Hospital Basel — Basel
  • University Hospital Bern — Bern
  • Lausanne University Hospital — Lausanne
  • Lucerne Cantonal Hospital — Lucerne
  • Cantonal Hospital Olten — Olten
  • Herzpraxis am Rhein — Rheinfelden
  • Solothurner Spitäler AG — Solothurn

Identifiers

NCT: NCT05890664 · 2023-00548, kt21sticherling

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗