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Targeting Inflammation in Acute Coronary Syndrome Using Colchicine (COOL)

This study has been completed.
Information provided by:
McMaster University Identifier:
First received: September 16, 2008
Last updated: October 7, 2009
Last verified: October 2009
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 Intervention Phase
Acute Coronary Syndrome Drug: Colchicine Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by McMaster University:

Primary Outcome Measures:
  • To determine the effect of low dose colchicine on hs-CRP. [ Time Frame: 30 days ]

Secondary Outcome Measures:
  • To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events [ Time Frame: 30 days ]

Enrollment: 80
Study Start Date: April 2008
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00754819

Canada, Ontario
Hamilton General Hospital
Hamilton, Ontario, Canada, L8L2X2
Sponsors and Collaborators
Hamilton Health Sciences Corporation
Study Director: John Eikelboom, FRACP FRCPA McMaster University
  More Information

Responsible Party: Dr John Eikelboom, McMaster University/ Hamilton Health Sciences Identifier: NCT00754819     History of Changes
Other Study ID Numbers: COL0001
Study First Received: September 16, 2008
Last Updated: October 7, 2009

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on September 21, 2017