Targeting Inflammation in Acute Coronary Syndrome Using Colchicine (COOL)

October 7, 2009 updated by: Hamilton Health Sciences Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L2X2
        • Hamilton General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To determine the effect of low dose colchicine on hs-CRP.
Time Frame: 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hamilton Health Sciences Corporation

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 16, 2008

First Submitted That Met QC Criteria

September 16, 2008

First Posted (Estimate)

September 18, 2008

Study Record Updates

Last Update Posted (Estimate)

October 8, 2009

Last Update Submitted That Met QC Criteria

October 7, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COL0001 (OnCore)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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