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Clinical Trials in Denmark / NCT05928728
Recruiting Phase 3

The COLchicine and Atrial FIBrillation Trial

NCT05928728 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 3
Started
2023-07-03
Last updated
2024-02-28

Condition(s) studied

Atrial Fibrillation

Investigational drug(s) / intervention(s)

Colchicine →Placebo

Colchicine: Colchicine 0.5 mg once daily

Placebo: Placebo once daily

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Living address in the Capital Region of Denmark 2. Age \> 18 3. Diagnosed with paroxysmic/persistent AF. 4. Planned or acute admission for cardioversion of AF with successful outcome. 5. 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 6. Participants will have given written, informed consent and are able and willing to comply with the requirements of the study protocol. 7. Optimal background therapy (in relation to comorbidities and development of heart failure / thromboembolic event) for AF as judged by the investigator. Exclusion Criteria: 1. Colchicine treatment for another cause, e.g. gout 2. Allergy/hypersensitivity to colchicine 3. Uncontrolled hypertension (systolic BP \>180 mmHg or diastolic BP \>110 mmHg) 4. 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 5. Cirrhosis, chronic active hepatitis or other severe hepatic disease 6. Hemodialysis 7. Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 8. Systemic treatment with moderate or strong cytochrome P450 3A4 (CYP3A4) inhibitors or P-glycoprotein inhibitors (list in Appendix 1) 9. Permanent AF 10. Female participants who are pregnant, lactating, or considering becoming pregnant during the study or for 6 months after study completion 11. Significant drug or alcohol abuse during the last year 12. Current use of or plans to initiate chronic systemic steroid therapy during the study (topical or inhaled steroids are allowed) 13. Planned ablation procedure as treatment for AF 14. If cardiovascular surgery or ablation has been done the past three months prior to inclusion. 15. Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea 16. Use of other investigational drugs within 30 days of the time of enrollment 17. 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. 18. Suspected AF, confirmed with ECG, at time of inclusion and randomization

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR) Hellerup Denmark Recruiting

More Herlev and Gentofte Hospital trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05928728 on ClinicalTrials.gov ↗ ← All trials in Denmark