Atrial FibrillationPhase 3COLFIBNCT05928728
The COLchicine and Atrial FIBrillation Trial
A Phase 3 study testing Colchicine in people with Atrial Fibrillation, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Colchicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteDenmark
- Study dates
- 3 Jul 2023to 1 Nov 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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 requirements of the study or completing the study.
- Suspected AF, confirmed with ECG, at time of inclusion and randomization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Translational Cardiology and Pragmatic Randomized Trials (CTCPR)
Hellerup, 2900
Adam Femerling Langhoff, MD, +4522552317, adam.femerling.langhoff@regionh.dk
Tor Biering-Sørensen, MD, PhD, MPH, +4528933590, tor.biering-soerensen@regionh.dk
About this study
Official title: The Colchicine and Atrial Fibrillation Trial
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.
Read the detailed description
The study is an investigator-initiated, prospective, double-blind, placebo-controlled, randomized clinical trial investigating the effects of colchicine in patients with atrial fibrillation (AF). The study population will consist of approximately 500 patients aged 18 years and above with a diagnosis of paroxysmic or persistent AF with a successful outcome of cardioversion. Patients will be randomized to either low-dose colchicine treatment (0,5 mg once daily) or placebo. Treatment will continue for 12 months. Patients will be assessed by measurement of time to first admission with AF (Electro Cardio Gram (ECG) confirmed), echocardiography, cardiac Magnetic Resonance Imaging (MRI), and blood samples at baseline and after 6 + 12 months.
- Conditions
- Atrial Fibrillation
- Being tested
- Colchicine, Placebo
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Colchicine 0.5 mg once daily
PlaceboDrug
Placebo once daily
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Not described Receives: Drug: Colchicine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Between-group difference in change in time to first AF admission measured in days
Measured: 12 months
Secondary outcomes (3)
Between-group difference in change in accumulated number of readmissions for symptomatic AF
Measured: 12 months
Between-group difference in change in Left Atrial Volume (LAV) assessed by echocardiography
Measured: 12 months
Between-group difference in change in Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) score
Score of 0 being the worst outcome and score of 100 being the best outcome
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start3 Jul 2023
- Primary completion14 Jun 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Femerling Langhoff, Herlev and Gentofte Hospital
- Investigators
- Adam Femerling Langhoff, M.D., Principal investigator, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928728
- Sponsor's protocol ID
- 2022-500850-40-01
- Acronym
- COLFIB
- Status last verified
- Feb 2024
- First submitted
- 14 Jun 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Colchicine and Atrial Fibrillation Trial
- ClinicalTrials.gov ID
- NCT05928728
- Acronym / sponsor ID
- COLFIB / 2022-500850-40-01
- Conditions
- Atrial Fibrillation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Study start
- 3 Jul 2023 (actual)
- Primary completion
- 14 Jun 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study is an investigator-initiated, prospective, double-blind, placebo-controlled, randomized clinical trial investigating the effects of colchicine in patients with atrial fibrillation (AF). The study population will consist of approximately 500 patients aged 18 years and above with a diagnosis of paroxysmic or persistent AF with a successful outcome of cardioversion. Patients will be randomized to either low-dose colchicine treatment (0,5 mg once daily) or placebo. Treatment will continue for 12 months. Patients will be assessed by measurement of time to first admission with AF (Electro Cardio Gram (ECG) confirmed), echocardiography, cardiac Magnetic Resonance Imaging (MRI), and blood samples at baseline and after 6 + 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: Colchicine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineColchicine 0.5 mg once daily | Drug | Colchicine |
| PlaceboPlacebo once daily | Drug | Placebo |
Primary outcome
Between-group difference in change in time to first AF admission measured in days
Time frame: 12 months
3 secondary outcomes
Between-group difference in change in accumulated number of readmissions for symptomatic AF
Time frame: 12 months
Between-group difference in change in Left Atrial Volume (LAV) assessed by echocardiography
Time frame: 12 months
Between-group difference in change in Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) score
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Adam Femerling Langhoff, M.D. principal investigator
Herlev and Gentofte Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine in people with Atrial Fibrillation, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Adam Femerling Langhoff, M.D. (+4522552317, adam.femerling.langhoff@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Between-group difference in change in time to first AF admission measured in days (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.