Targeting Inflammation in Acute Coronary Syndrome Using Colchicine (COOL)

This study has been completed.
Sponsor:
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00754819
First received: September 16, 2008
Last updated: October 7, 2009
Last verified: October 2009

September 16, 2008
October 7, 2009
April 2008
September 2009   (final data collection date for primary outcome measure)
To determine the effect of low dose colchicine on hs-CRP. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00754819 on ClinicalTrials.gov Archive Site
To determine the effect of colchicine on (a)platelet function and (b)short-term risk (30 days) of cardiovascular events [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Targeting Inflammation in Acute Coronary Syndrome Using Colchicine
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Colchicine
    1mg once daily
  • Drug: Placebo
    1 capsule daily
  • Active Comparator: 1
    Colchicine 1mg daily oral
    Intervention: Drug: Colchicine
  • Placebo Comparator: 2
    Placebo 1 capsule daily oral
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
September 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00754819
COL0001
Yes
Dr John Eikelboom, McMaster University/ Hamilton Health Sciences
Hamilton Health Sciences Corporation
Not Provided
Study Director: John Eikelboom, FRACP FRCPA McMaster University
McMaster University
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP