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NCT Number: NCT05890664

Colchicine After Electrocardioversion for Atrial Fibrillation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cantonal Hospital Baselland (KSBL), Bruderholz, Basel-Landschaft, Switzerland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine

Drug

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

Drug

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 outcomes

  1. Number of atrial fibrillation (AF) recurrence

    Time frame: 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 outcomes

  1. Number of atrial fibrillation (AF) recurrence

    Time frame: within 1 month after electrocardioversion

    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.

  2. Number of atrial fibrillation (AF) recurrence

    Time frame: 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.

  3. Time to first redo electrocardioversion

    Time frame: up to 6 month

    Time to first redo electrocardioversion

  4. Use of antiarrhythmic drugs

    Time frame: 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)

  5. Number of survived participants without an unplanned hospital stay

    Time frame: up to 6 month

    Number of survived participants without an unplanned hospital stay

Study contacts

Contact information is provided by the study sponsor or research team.

Philipp Krisai, PD Dr. med.

CONTACT

[email protected]

+41 61 265 25 25

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Fondation Machaon, Switzerland, Genf
  • Foundation for Cardiovascular Research Basel
  • Swiss Heart Foundation

Registry information

Official study title

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

Acronym: COLECTRO-AF

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 6, 2023
Registry last updated
May 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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