Back to resultsColchicine in Atrial Fibrillation to Prevent Stroke (CIAFS-1)
Primary Purpose
Atrial Fibrillation, Stroke
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Colchicine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Atrial Fibrillation focused on measuring Atrial fibrillation, Arrhythmias, Cardiac, Stroke, agents, anti inflammatory, D-dimer, C-reactive protein
Eligibility Criteria
Inclusion Criteria:
- Patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.
Exclusion Criteria:
- 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.
Sites / Locations
- Hamilton General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Colchicine
Placebo Colchicine
Arm Description
The intervention group will receive colchicine 0.6 mg twice daily orally for 3 months
The control group will receive colchicine placebo 0.6mg twice daily orally for 3 months.
Outcomes
Primary Outcome Measures
Recruitment rates
Number of eligible patients successfully randomized into study per year of study.
Drop-out rates
Proportion of participants withdrawing from study for any reason
Secondary Outcome Measures
D-dimer
Mean D-dimer level at baseline and Month 3 for each arm
hs-CRP
Mean level of hs-CRP at baseline and month 3 for each arm
Proportion of patients with a clinically significant adverse event
Proportion of patients with side effects such as diarrhoea, myopathy requiring drug cessation
Drug adherence
Proportion of missing pill to dispensed pill at 6 weeks and month 3
Full Information
NCT ID
NCT02282098
First Posted
October 29, 2014
Last Updated
February 19, 2021
Sponsor
Population Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT02282098
Brief Title
Colchicine in Atrial Fibrillation to Prevent Stroke
Acronym
CIAFS-1
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
November 17, 2020 (Actual)
Study Completion Date
November 17, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Population Health Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation, Stroke
Keywords
Atrial fibrillation, Arrhythmias, Cardiac, Stroke, agents, anti inflammatory, D-dimer, C-reactive protein
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Colchicine
Arm Type
Experimental
Arm Description
The intervention group will receive colchicine 0.6 mg twice daily orally for 3 months
Arm Title
Placebo Colchicine
Arm Type
Placebo Comparator
Arm Description
The control group will receive colchicine placebo 0.6mg twice daily orally for 3 months.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Other Intervention Name(s)
pms-Colchicine
Intervention Description
Colchicine 0.6mg twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Capsule
Intervention Description
Placebo Colchicine
Primary Outcome Measure Information:
Title
Recruitment rates
Description
Number of eligible patients successfully randomized into study per year of study.
Time Frame
Randomization to Month 3
Title
Drop-out rates
Description
Proportion of participants withdrawing from study for any reason
Time Frame
Randomization to Month 3
Secondary Outcome Measure Information:
Title
D-dimer
Description
Mean D-dimer level at baseline and Month 3 for each arm
Time Frame
Randomization to Month 3
Title
hs-CRP
Description
Mean level of hs-CRP at baseline and month 3 for each arm
Time Frame
Randomization to Month 3
Title
Proportion of patients with a clinically significant adverse event
Description
Proportion of patients with side effects such as diarrhoea, myopathy requiring drug cessation
Time Frame
Randomization to Month 3
Title
Drug adherence
Description
Proportion of missing pill to dispensed pill at 6 weeks and month 3
Time Frame
Randomization to Month 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noel Chan, MD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Eikelboom, MD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Colchicine in Atrial Fibrillation to Prevent Stroke
We'll reach out to this number within 24 hrs