Colchicine and atrial fibrillation or flutter returning after cardioversion
Tests colchicine in people having cardioversion for atrial fibrillation or flutter.
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
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with atrial fibrillation that comes and goes or lasts a long time, who are having an electrical shock to the heart to restore normal rhythm. It tests colchicine against the return of the irregular rhythm.
- Age
- Older than 18 years
- Sex
- Women and men can join. Women who can have children must use hormonal birth control or an intrauterine device during the study and for 30 days after it.
- Disease stage
- Atrial fibrillation or atrial flutter that comes and goes (paroxysmal) or lasts a long time (persistent). Planned or urgent admission for an electrical shock to the heart (cardioversion) that worked.
- Earlier treatment
- Must be on the best background treatment for atrial fibrillation, as judged by the study doctor. Must not take colchicine for another reason, such as gout.
Main reasons for not taking part
- Permanent atrial fibrillation, or atrial fibrillation seen on ECG when joining
- Allergy to colchicine, or taking colchicine for another reason
- Kidney problems (eGFR below 45 mL/min/1.73 m2) or haemodialysis
- Severe liver disease, or cancer in the last 5 years (some skin and localized cancers are allowed)
- Pregnant or breastfeeding, or planning a pregnancy during the study or for 6 months after it
Read by machine on 11 November 2026.
Where in Denmark
- Gentofte HospitalHellerup, 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?
Contact the study team: see the registry record
Print a page for my doctorTrial details
- Who runs it
- Gentofte Hospital
- Trial code
- EU 2022-500850-40-01
- Record updated
- 14 October 2024
- Original description
The purpose of this study is to investigate the beneficial effects of colchicine on Atrial Fibrillation and atrial flutter (henceforth under joint abbreviation as AF) recurrence in patients scheduled for electrical cardioversion for AF. We expect the results of this clinical trial to indicate whether colchicine should be repurposed for the treatment of paroxysmic/persistent AF.Read full original descriptionShow less
The Colchicine and atrial fibrillation trial
The purpose of this study is to investigate the beneficial effects of colchicine on Atrial Fibrillation and atrial flutter (henceforth under joint abbreviation as AF) recurrence in patients scheduled for electrical cardioversion for AF. We expect the results of this clinical trial to indicate whether colchicine should be repurposed for the treatment of paroxysmic/persistent AF.
Inclusion: Age > 18; Diagnosed with paroxystic/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 within the last 5 years 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) < 45 mL/min/1.73 m2; Colchicine treatment for another cause, e.g. gout; Hemodialysis; Permanent AF; Suspected AF, confirmed with ECG, at time of inclusion and randomization; 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.