Tests colchicine in people with atrial fibrillation
Tests whether colchicine, compared with a placebo, affects atrial fibrillation in adults.
Plain-language title generated from the registry record
Registry title: The COLchicine and Atrial FIBrillation Trial
Key facts
- Where
- Hellerup, DenmarkSee the site
- Phase
- Phase 3
Where in Denmark
- Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)Hellerup, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Herlev and Gentofte Hospital
- Trial code
- NCT05928728
- Record updated
- 28 February 2024
- Original description
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.Read full original descriptionShow less
The Colchicine and Atrial Fibrillation Trial
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.
Inclusion: 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: Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1); 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); If cardiovascular surgery or ablation has been done the past three months prior to inclusion; Use of other investigational drugs within 30 days of the time of enrollment; 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; Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea; 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; Estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m2; Colchicine treatment for another cause, e.g. gout; Hemodialysis; Permanent AF; Female participants who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion; Planned ablation procedure as treatment for AF; Suspected AF, confirmed with ECG, at time of inclusion and randomization.