Atrial FibrillationPhase 3CIAFS-1NCT02282098
Colchicine in Atrial Fibrillation to Prevent Stroke
A Phase 3 study testing Colchicine in people with Atrial Fibrillation and Stroke, run by Population Health Research Institute at 1 site in Canada.
Trial summary
The purpose of this study is to determine the feasibility of performing a randomized controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to 17 Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.
Who cannot join
- Contraindications to colchicine such as allergy/hypersensitivity,
- Receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, anti-neoplastic, Interleukin 1-1b antagonist, Tumor necrosis factor-alpha inhibitor),
- Receiving food or co-medications such as strong-moderate cytochrome P450 3A4 inhibitors that will result in elevated plasma level of colchicine,
- Inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infection,
- Severe renal (eGFR< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST > 2x Upper limit of normal),
- Moderate or severe cytopenias (platelet < 100, neutrophil count < 1.5) or existing blood dyscrasia (e.g., myelodysplasia)
- Pregnant or lactating woman or woman of child bearing age no protected by reliable contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Targeting Inflammation in Atrial Fibrillation to Prevent Ischemic Stroke: A Feasibility Study Evaluating the Effect of Colchicine on D-dimer and Hs-CRP in Anticoagulated Patients With Atrial Fibrillation
The purpose of this study is to determine the feasibility of performing a randomized controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP).
Read the detailed description
Atrial fibrillation (AF), the most common cardiac arrhythmia (with a global burden of 33.5 million affected patients in 2010), is responsible for about 20% of ischemic stroke, a major cause of morbidity and mortality. Anticoagulants are very effective in reducing the risk of stroke in AF but on average 10-15% of treated patients still experience a stroke over a 10-year period and in selected elderly populations the risk is even higher. We hypothesize that thrombosis mediated by inflammation might be responsible for the residual risk of stroke, despite anticoagulant therapy and that targeting inflammation has the potential to reduce thrombosis and the risk of stroke in anticoagulated patients with AF.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Colchicine, Placebo
- Keywords
- Atrial fibrillation, Arrhythmias, Cardiac, Stroke, agents, anti inflammatory, D-dimer, C-reactive protein
- Medical subject headings
- Atrial Fibrillation, Stroke, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called pms-Colchicine
Colchicine 0.6mg twice daily
PlaceboDrug
Also called Placebo Capsule
Placebo Colchicine
| Study group | Role | What they receive |
|---|---|---|
| Active Colchicine | Experimental | The intervention group will receive colchicine 0.6 mg twice daily orally for 3 months Receives: Drug: Colchicine |
| Placebo Colchicine | Placebo comparator | The control group will receive colchicine placebo 0.6mg twice daily orally for 3 months. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rates
Number of eligible patients successfully randomized into study per year of study.
Measured: Randomization to Month 3
Drop-out rates
Proportion of participants withdrawing from study for any reason
Measured: Randomization to Month 3
Secondary outcomes (4)
D-dimer
Mean D-dimer level at baseline and Month 3 for each arm
Measured: Randomization to Month 3
hs-CRP
Mean level of hs-CRP at baseline and month 3 for each arm
Measured: Randomization to Month 3
Proportion of patients with a clinically significant adverse event
Proportion of patients with side effects such as diarrhoea, myopathy requiring drug cessation
Measured: Randomization to Month 3
Drug adherence
Proportion of missing pill to dispensed pill at 6 weeks and month 3
Measured: Randomization to Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startNov 2014
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noel Chan, Population Health Research Institute
- Investigators
- Noel Chan, MD, Principal investigator, Population Health Research InstituteJohn Eikelboom, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282098
- Sponsor's protocol ID
- NIF-14350
- Other IDs
- NIF-14350
- Acronym
- CIAFS-1
- Status last verified
- Feb 2021
- First submitted
- 29 Oct 2014
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Inflammation in Atrial Fibrillation to Prevent Ischemic Stroke: A Feasibility Study Evaluating the Effect of Colchicine on D-dimer and Hs-CRP in Anticoagulated Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT02282098
- Acronym / sponsor ID
- CIAFS-1 / NIF-14350
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- Atrial fibrillation, Arrhythmias, Cardiac, Stroke, agents, anti inflammatory, D-dimer, C-reactive protein
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 4 Nov 2014 (estimated)
- 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 is to determine the feasibility of performing a randomized controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP).
Detailed description
Atrial fibrillation (AF), the most common cardiac arrhythmia (with a global burden of 33.5 million affected patients in 2010), is responsible for about 20% of ischemic stroke, a major cause of morbidity and mortality. Anticoagulants are very effective in reducing the risk of stroke in AF but on average 10-15% of treated patients still experience a stroke over a 10-year period and in selected elderly populations the risk is even higher. We hypothesize that thrombosis mediated by inflammation might be responsible for the residual risk of stroke, despite anticoagulant therapy and that targeting inflammation has the potential to reduce thrombosis and the risk of stroke in anticoagulated patients with AF.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Colchicine | Experimental | Drug: ColchicineThe intervention group will receive colchicine 0.6 mg twice daily orally for 3 months |
| Placebo Colchicine | Placebo comparator | Drug: PlaceboThe control group will receive colchicine placebo 0.6mg twice daily orally for 3 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.
Key exclusion criteria (7 listed)
- Contraindications to colchicine such as allergy/hypersensitivity,
- Receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, anti-neoplastic, Interleukin 1-1b antagonist, Tumor necrosis factor-alpha inhibitor),
- Receiving food or co-medications such as strong-moderate cytochrome P450 3A4 inhibitors that will result in elevated plasma level of colchicine,
- Inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infection,
- Severe renal (eGFR< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST > 2x Upper limit of normal),
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 |
|---|---|---|
| ColchicineAlso: pms-ColchicineColchicine 0.6mg twice daily | Drug | Active Colchicine |
| PlaceboAlso: Placebo CapsulePlacebo Colchicine | Drug | Placebo Colchicine |
Primary outcome
Recruitment rates
Time frame: Randomization to Month 3
Number of eligible patients successfully randomized into study per year of study.
Drop-out rates
Time frame: Randomization to Month 3
Proportion of participants withdrawing from study for any reason
4 secondary outcomes
D-dimer
Time frame: Randomization to Month 3
hs-CRP
Time frame: Randomization to Month 3
Proportion of patients with a clinically significant adverse event
Time frame: Randomization to Month 3
Drug adherence
Time frame: Randomization to Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
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Paroxysmal AF
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Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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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. This study is not recruiting at the moment.
Noel Chan, MD principal investigator
Population Health Research Institute
John Eikelboom, MD principal investigator
Population Health Research Institute
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 and Stroke, run by Population Health Research Institute at 1 site in Canada.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 23 Feb 2021. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rates (time frame: Randomization to Month 3). The study lists 2 primary outcomes in all. 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 23 Feb 2021; AzTrials last refreshed its copy on 6 Nov 2026.