COOL: Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

• Sponsor: Hamilton Health Sciences Corporation (Other)
• Overall Status: Completed
• CT.gov ID: NCT00754819
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome	Drug: Colchicine; Drug: Placebo	Phase 2/Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Colchicine Compared With Placebo to Reduce Hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial
• Study Start Date: Apr 1, 2008
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Colchicine 1mg daily oral	Drug: Colchicine; 1mg once daily
Placebo Comparator: 2 Placebo 1 capsule daily oral	Drug: Placebo; 1 capsule daily

Outcome Measures

Primary Outcome Measures

1. To determine the effect of low dose colchicine on hs-CRP. [30 days]

Secondary Outcome Measures

1. To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamilton General Hospital	Hamilton	Ontario	Canada	L8L2X2

Sponsors and Collaborators

• Hamilton Health Sciences Corporation

Investigators

• Study Director: John Eikelboom, FRACP FRCPA, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00754819
• Other Study ID Numbers: COL0001
• First Posted: Sep 18, 2008
• Last Update Posted: Oct 8, 2009
• Last Verified: Oct 1, 2009

• Additional relevant MeSH terms: Acute Coronary Syndrome; Syndrome; Inflammation; Colchicine

Study Results

No Results Posted as of Oct 8, 2009