Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

Acute Coronary Syndrome Clinical Trial

— COOL  

Official title:

Colchicine Compared With Placebo to Reduce Hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00754819
• Other study ID #: COL0001
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 16, 2008
• Last updated: October 7, 2009
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: October 2009
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Inflammation
• Syndrome

Intervention

Drug:
• Colchicine
1mg once daily
• Placebo
1 capsule daily

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the effect of low dose colchicine on hs-CRP.		30 days
Secondary	To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events		30 days