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New treatment option for Atrial Fibrillation
Official title The COLchicine and Atrial FIBrillation Trial
ClinicalTrials.gov ID: NCT05928728
What this study is testing
What is Colchicine?
Colchicine is an investigational medicine, given as an once-daily, being studied as a potential treatment for atrial fibrillation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join 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...
- Cirrhosis, chronic active hepatitis or other severe hepatic disease
- Hemodialysis
See the full eligibility 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 as postmenopausal for at least 1 year or surgically sterile, or is of childbearing potential and practicing one of the following methods of...
- 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.
- 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...
- Suspected AF, confirmed with ECG, at time of inclusion and randomization
The study team makes the final eligibility decision.
Where it's taking place
- Hellerup, Denmark
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hellerup, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.