Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Treatments: Colchicine

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