Clinical trial

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

Name

2023-00548, kt21sticherling

Description

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.

Trial arms

Trial start

2024-04-14

Estimated PCD

2025-12-01

Trial end

2025-12-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Experimental Group

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.

Arms:

Control Group

Size

416

Primary endpoint

Number of atrial fibrillation (AF) recurrence

within 6 month after electrocardioversion

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 ≥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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, randomized, double-blind, placebo-controlled trial.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "A randomization list will be provided by the Clinical Trial Unit Basel to an unblinded person at the sponsor's site. The unblinded person will allocate the randomization numbers. Patients and research staff involved in patient recruitment, data management, outcome adjudication and data analyses will fully be blinded", 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 416, 'type': 'ESTIMATED'}}

Updated at

2024-04-17

1 organization

2 products

2 indications

Organization

University Hospital Basel

Product

Indication

Indication

Product