The COLchicine and Atrial FIBrillation Trial
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Atrial Fibrillation
In brief
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.
Key facts
- Study ID
- NCT05928728
- Run by
- Herlev and Gentofte Hospital
- People needed
- 500
- Starts
- 2023-07-03
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2024-02-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) — Hellerup, Denmark (enrolling)
Full record on ClinicalTrials.gov
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