Status:
COMPLETED
Colchicine in Atrial Fibrillation to Prevent Stroke
Lead Sponsor:
Population Health Research Institute
Conditions:
Atrial Fibrillation
Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 m...
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 morbidi...
Eligibility Criteria
Inclusion
- Patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2020
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT02282098
Start Date
November 1 2014
End Date
November 17 2020
Last Update
February 23 2021
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2