The COLchicine and Atrial FIBrillation Trial
COLFIB
The Colchicine and Atrial Fibrillation Trial
1 other identifier
interventional
500
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 atrial-fibrillation
Started Jul 2023
Longer than P75 for phase_3 atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
July 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
February 28, 2024
February 1, 2024
3 years
June 14, 2023
February 27, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Between-group difference in change in time to first AF admission measured in days
12 months
Secondary Outcomes (3)
Between-group difference in change in accumulated number of readmissions for symptomatic AF
12 months
Between-group difference in change in Left Atrial Volume (LAV) assessed by echocardiography
12 months
Between-group difference in change in Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) score
12 months
Other Outcomes (20)
Between-group difference in change in plasma concentration of high sensitivity C-Reactive Protein (hs-CRP)
12 months
Between-group difference in change in plasma concentration of high sensitivity Troponin I (hs-TnI)
12 months
Between-group difference in change in Left Ventricle (LV) septal wall thickness assessed by echocardiography
12 months
- +17 more other outcomes
Study Arms (2)
Colchicine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify 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 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.
You may not qualify 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 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)
Hellerup, 2900, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam Femerling Langhoff, M.D.
Herlev and Gentofte Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 14, 2023
First Posted
July 3, 2023
Study Start
July 3, 2023
Primary Completion (Estimated)
June 14, 2026
Study Completion (Estimated)
November 1, 2028
Last Updated
February 28, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share