Actively Recruiting
The COLchicine and Atrial FIBrillation Trial
Led by Herlev and Gentofte Hospital · Updated on 2024-02-28
500
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The COLchicine and Atrial FIBrillation Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Living in the Capital Region of Denmark
- Age above 18 years
- Diagnosed with paroxysmic or persistent atrial fibrillation
- Planned or acute admission for cardioversion of atrial fibrillation with a successful outcome
- Female participants must either be postmenopausal for at least 1 year, surgically sterile, or using effective contraception during the study and for 30 days after
- Able and willing to provide written informed consent and comply with study requirements
- Receiving optimal background therapy for atrial fibrillation and related conditions as judged by the investigator
You will not qualify if you...
- Currently receiving colchicine treatment for other conditions
- Allergy or hypersensitivity to colchicine
- Uncontrolled high blood pressure (systolic >180 mmHg or diastolic >110 mmHg)
- History of malignancy except certain localized or successfully treated cancers
- Severe liver disease such as cirrhosis or chronic active hepatitis
- Receiving hemodialysis
- Estimated glomerular filtration rate below 60 mL/min/1.73 m2
- Using moderate or strong CYP3A4 or P-glycoprotein inhibitors
- Permanent atrial fibrillation
- Pregnant, lactating, or planning pregnancy during the study or for 6 months after
- Significant drug or alcohol abuse in the past year
- Current or planned chronic systemic steroid therapy (topical or inhaled steroids allowed)
- Planned ablation procedure for atrial fibrillation
- Cardiovascular surgery or ablation within 3 months before enrollment
- Chronic inflammatory bowel disease or chronic diarrhea
- Use of other investigational drugs within 30 days before enrollment
- Any medical or surgical condition that increases risk or may prevent study completion
- Atrial fibrillation not confirmed by ECG at inclusion and randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)
Hellerup, Denmark, 2900
Actively Recruiting
Research Team
A
Adam Femerling Langhoff, M.D.
CONTACT
T
Tor Biering-Sørensen, MD, PhD, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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