Colchicine After Electrocardioversion for Atrial Fibrillation
NCT ID: NCT05890664
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
416 participants
INTERVENTIONAL
2024-04-14
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Experimental Group
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.
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.
Control Group
Study participants in the placebo group will receive a matched placebo.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Swiss Heart Foundation
OTHER
Fondation Machaon, Switzerland, Genf
UNKNOWN
Foundation for Cardiovascular Research Basel
UNKNOWN
University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Philipp Krisai, PD Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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Cantonal Hospital Baselland (KSBL)
Bruderholz, Basel-Landschaft, Switzerland
University Hospital Basel
Basel, , Switzerland
University Hospital Bern
Bern, , Switzerland
Lausanne University Hospital
Lausanne, , Switzerland
Lucerne Cantonal Hospital
Lucerne, , Switzerland
Cantonal Hospital Olten
Olten, , Switzerland
Herzpraxis am Rhein
Rheinfelden, , Switzerland
Solothurner Spitäler AG
Solothurn, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-00548, kt21sticherling
Identifier Type: -
Identifier Source: org_study_id
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