Status:
COMPLETED
Targeting Inflammation in Acute Coronary Syndrome Using Colchicine
Lead Sponsor:
Hamilton Health Sciences Corporation
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the effect of colchicine on high sensitivity C-reactive protein (hs-CRP), a blood marker to measure inflammation, in patients with acute coronary syndromes.
Eligibility Criteria
Inclusion
- All patients with a diagnosis of acute coronary syndrome who are \> 18 years old and who do not have any contraindication to colchicine.
Exclusion
- Contraindication to colchicine including any of the following:
- hypersensitivity to colchicine
- severe renal, hepatic or gastrointestinal disorder
- blood dyscrasias (myelodysplasia cytopenias etc)
- Concurrent use of moderate-strong CYP3A4 inhibitors (a complete list is appended in the full protocol)
- Known severe liver disease and/or elevated transaminases \> 1.5x the upper limit of normal
- Estimated GFR \< 50 ml/min
- Pregnant or lactating women or women not protected by a reliable contraception method
- Current treatment with colchicine at enrollment
- Active infection or systemic inflammation eg active rheumatoid arthritis
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00754819
Start Date
April 1 2008
End Date
September 1 2009
Last Update
October 8 2009
Active Locations (1)
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1
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2