Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2023-07-03
2028-11-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Colchicine in Atrial Fibrillation to Prevent Stroke
NCT02282098
Clinical Trial to Improve Treatment With Blood Thinners in Patients With Atrial Fibrillation
NCT02082548
Efficacy and Safety of Aspirin and Clopidogrel in the Atrial Fibrillation With Low or Moderate Stroke Risk
NCT02960126
Direct Oral Anticoagulants in Patients with Atrial Fibrillation (DOACs Vs Warfarin)
NCT03596502
Effect of Antithrombotic Treatment in Patients With Both Coronary Heart Disease and Atrial Fibrillation
NCT03051061
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Colchicine
Colchicine
Colchicine 0.5 mg once daily
Placebo
Placebo
Placebo once daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Colchicine
Colchicine 0.5 mg once daily
Placebo
Placebo once daily
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Herlev and Gentofte Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Adam Femerling Langhoff
Principal Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Adam Femerling Langhoff, M.D.
Role: PRINCIPAL_INVESTIGATOR
Herlev and Gentofte Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)
Hellerup, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2022-500850-40-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.