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Targeting Inflammation in Acute Coronary Syndrome Using Colchicine (COOL)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Colchicine
Placebo
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hamilton General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Colchicine 1mg daily oral

Placebo 1 capsule daily oral

Outcomes

Primary Outcome Measures

To determine the effect of low dose colchicine on hs-CRP.

Secondary Outcome Measures

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

Full Information

First Posted
September 16, 2008
Last Updated
October 7, 2009
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00754819
Brief Title
Targeting Inflammation in Acute Coronary Syndrome Using Colchicine
Acronym
COOL
Official Title
Colchicine Compared With Placebo to Reduce Hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Colchicine 1mg daily oral
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo 1 capsule daily oral
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
1mg once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 capsule daily
Primary Outcome Measure Information:
Title
To determine the effect of low dose colchicine on hs-CRP.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Eikelboom, FRACP FRCPA
Organizational Affiliation
McMaster University
Official's Role
Study Director
Facility Information:
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L2X2
Country
Canada

12. IPD Sharing Statement

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Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

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