Targeting Inflammation in Acute Coronary Syndrome Using Colchicine
- Registration Number
- NCT00754819
- Lead Sponsor
- Hamilton Health Sciences Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- All patients with a diagnosis of acute coronary syndrome who are > 18 years old and who do not have any contraindication to colchicine.
Exclusion Criteria
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Colchicine Colchicine 1mg daily oral 2 Placebo Placebo 1 capsule daily oral
- Primary Outcome Measures
Name Time Method To determine the effect of low dose colchicine on hs-CRP. 30 days
- Secondary Outcome Measures
Name Time Method To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events 30 days
Trial Locations
- Locations (1)
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada