Targeting Inflammation in Acute Coronary Syndrome Using Colchicine
Information source: McMaster University
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Coronary Syndrome
Intervention: Colchicine (Drug); Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Hamilton Health Sciences Corporation Official(s) and/or principal investigator(s):
John Eikelboom, FRACP FRCPA, Study Director, Affiliation: McMaster University
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.
Clinical Details
Official title: Colchicine Compared With Placebo to Reduce Hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: To determine the effect of low dose colchicine on hs-CRP.
Secondary outcome: To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events
Eligibility
Minimum age: 18 Years.
Maximum age: 85 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Hamilton General Hospital, Hamilton, Ontario L8L2X2, Canada
Additional Information
Starting date: April 2008
Last updated: October 7, 2009
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