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Sponsored by: |
Hamilton Health Sciences |
---|---|
Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00754819 |
The purpose of this study is to evaluate the effect of colchicine on hs-CRP, a blood marker to measure inflammation, in patients with acute coronary syndromes.
Condition | Intervention | Phase |
---|---|---|
Acute Coronary Syndrome |
Drug: Colchicine Drug: Placebo |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Colchicine Compared With Placebo to Reduce hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial |
Estimated Enrollment: | 80 |
Study Start Date: | April 2008 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Colchicine 1mg daily
|
Drug: Colchicine
1mg once daily
|
2: Placebo Comparator
Placebo
|
Drug: Placebo
1 capsule daily
|
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contraindication to colchicine including any of the following: *hypersensitivity to colchicine
Contact: John Eikelboom, FRACP FRCPA | 9055274322 ext 44678 | eikelbj@mcmaster.ca |
Canada, Ontario | |
Hamilton General Hospital | Recruiting |
Hamilton, Ontario, Canada, L8L2X2 | |
Contact: Nina Raju 9055274322 ext 44709 nraju1@cogeco.ca | |
Principal Investigator: Nina Raju | |
Principal Investigator: John Eikelboom |
Study Director: | John Eikelboom, FRACP FRCPA | McMaster University |
Responsible Party: | McMaster University/ Hamilton Health Sciences ( Dr John Eikelboom ) |
Study ID Numbers: | COL0001 |
Study First Received: | September 16, 2008 |
Last Updated: | September 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00754819 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Atherosclerosis Heart Diseases Myocardial Ischemia Tubulin Modulators Acute Coronary Syndrome Vascular Diseases |
Colchicine Antimitotic Agents Ischemia Antirheumatic Agents Inflammation |
Disease Heart Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myocardial Ischemia Mitosis Modulators Vascular Diseases Antimitotic Agents Gout Suppressants Pharmacologic Actions |
Inflammation Pathologic Processes Therapeutic Uses Syndrome Acute Coronary Syndrome Tubulin Modulators Cardiovascular Diseases Colchicine Antirheumatic Agents |