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Recruiting NCT05928728

The COLchicine and Atrial FIBrillation Trial

Phase III Interventional Atrial Fibrillation

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. 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
Denmark
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

The Colchicine and Atrial Fibrillation Trial

Overview

The purpose of this study to investigate the effects of colchicine on atrial fibrillation recurrence and vascular and cardiac function in patients with atrial fibrillation.

Detailed description

The study is an investigator-initiated, prospective, double-blind, placebo-controlled, randomized clinical trial investigating the effects of colchicine in patients with atrial fibrillation (AF). The study population will consist of approximately 500 patients aged 18 years and above with a diagnosis of paroxysmic or persistent AF with a successful outcome of cardioversion. Patients will be randomized to either low-dose colchicine treatment (0,5 mg once daily) or placebo. Treatment will continue for 12 months. Patients will be assessed by measurement of time to first admission with AF (Electro Cardio Gram (ECG) confirmed), echocardiography, cardiac Magnetic Resonance Imaging (MRI), and blood samples at baseline and after 6 + 12 months.

Interventions

  • Drug Colchicine
    Colchicine 0.5 mg once daily
  • Drug Placebo
    Placebo once daily

Primary outcome measures

  • Between-group difference in change in time to first AF admission measured in days [Time frame: 12 months]
Secondary outcome measures (3)
  • Between-group difference in change in accumulated number of readmissions for symptomatic AF [Time frame: 12 months]
  • Between-group difference in change in Left Atrial Volume (LAV) assessed by echocardiography [Time frame: 12 months]
  • Between-group difference in change in Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) score [Time frame: 12 months]

Eligibility criteria

Inclusion criteria

  • Living address in the Capital Region of Denmark
  • Age > 18
  • Diagnosed with paroxysmic/persistent AF.
  • Planned or acute admission for cardioversion of AF with successful outcome.
  • Female participants should either not be of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of contraception throughout the study and for 30 days after study completion: Hormonal contraception (oral contraceptives, contraceptive implant, injectable birth control, contraceptive patch, or vaginal ring) or intrauterine device
  • Participants will have given written, informed consent and are able and willing to comply with the requirements of the study protocol.
  • Optimal background therapy (in relation to comorbidities and development of heart failure / thromboembolic event) for AF as judged by the investigator.

Exclusion criteria

  • Colchicine treatment for another cause, e.g. gout
  • Allergy/hypersensitivity to colchicine
  • Uncontrolled hypertension (systolic BP >180 mmHg or diastolic BP >110 mmHg)
  • History of malignancy of any organ system excluding a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostate cancer and/or localized carcinoma in situ of the cervix
  • Cirrhosis, chronic active hepatitis or other severe hepatic disease
  • Hemodialysis
  • Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2
  • Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1)
  • Permanent AF
  • Female participants who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion
  • Significant drug or alcohol abuse during the last year
  • Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed)
  • Planned ablation procedure as treatment for AF
  • If cardiovascular surgery or ablation has been done the past three months prior to inclusion.
  • Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
  • Use of other investigational drugs within 30 days of the time of enrollment
  • Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
  • Suspected AF, confirmed with ECG, at time of inclusion and randomization

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
Quadruple blind
Primary purpose
Treatment

Study locations

Denmark · 1 center
  • Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) — Hellerup

Identifiers

NCT: NCT05928728 · 2022-500850-40-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗