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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00754819

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

No publications provided

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

Additional relevant MeSH terms:
Inflammation
Syndrome
Acute Coronary Syndrome
Pathologic Processes
Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Colchicine
Gout Suppressants
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 18, 2014