Last updated: February 27, 2024
Sponsor: Herlev and Gentofte Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Chest Pain
Arrhythmia
Cardiac Disease
Treatment
Colchicine
Placebo
Clinical Study ID
NCT05928728
2022-500850-40-01
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 aspostmenopausal for at least 1 year or surgically sterile, or is of childbearingpotential and practicing one of the following methods of contraception throughout thestudy and for 30 days after study completion: Hormonal contraception (oralcontraceptives, 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 tocomply with the requirements of the study protocol.
- Optimal background therapy (in relation to comorbidities and development of heartfailure / thromboembolic event) for AF as judged by the investigator.
Exclusion
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 treatednon-metastatic cutaneous squamous cell or basal cell carcinoma, localized prostatecancer 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 orP-glycoprotein inhibitors (list in Appendix 1)
- Permanent AF
- Female participants who are pregnant, lactating, or considering becoming pregnantduring 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 toinclusion.
- Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronicdiarrhea
- 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 placethe patient at higher risk from his/her participation in the study, or is likely toprevent the patient from complying with the requirements of the study or completingthe study.
- Suspected AF, confirmed with ECG, at time of inclusion and randomization
Study Design
Total Participants: 500
Treatment Group(s): 2
Primary Treatment: Colchicine
Phase: 3
Study Start date:
July 03, 2023
Estimated Completion Date:
November 01, 2028
Study Description
Connect with a study center
Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)
Hellerup, 2900
DenmarkActive - Recruiting

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