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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

Page last updated: August 20, 2015

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