Targeting Inflammation in Acute Coronary Syndrome Using Colchicine - Full Text View

Targeting Inflammation in Acute Coronary Syndrome Using Colchicine (COOL)

This study is currently recruiting participants.

Verified by McMaster University, September 2008

First Received: September 16, 2008 No Changes Posted

Sponsored by:	Hamilton Health Sciences
Information provided by:	McMaster University
ClinicalTrials.gov Identifier:	NCT00754819

Purpose

The purpose of this study is to evaluate the effect of colchicine on 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 II Phase III

Drug Information available for: Colchicine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Colchicine Compared With Placebo to Reduce hs-CRP in Patients With Acute Coronary Syndromes- Targeting Inflammation in Atherosclerosis Trial

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 ]

Estimated Enrollment:	80
Study Start Date:	April 2008
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Colchicine 1mg daily	Drug: Colchicine 1mg once daily
2: Placebo Comparator Placebo	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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754819

Contacts

Contact: John Eikelboom, FRACP FRCPA

9055274322 ext 44678

eikelbj@mcmaster.ca

Locations

Canada, Ontario
Hamilton General Hospital	Recruiting
Hamilton, Ontario, Canada, L8L2X2
Contact: Nina Raju 9055274322 ext 44709 nraju1@cogeco.ca
Principal Investigator: Nina Raju
Principal Investigator: John Eikelboom

Sponsors and Collaborators

Hamilton Health Sciences

Investigators

Study Director:

John Eikelboom, FRACP FRCPA

McMaster University

More Information

No publications provided

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

Study placed in the following topic categories:

Atherosclerosis
Heart Diseases
Myocardial Ischemia
Tubulin Modulators
Acute Coronary Syndrome
Vascular Diseases

Colchicine
Antimitotic Agents
Ischemia
Antirheumatic Agents
Inflammation

Additional relevant MeSH terms:

Disease
Heart Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myocardial Ischemia
Mitosis Modulators
Vascular Diseases
Antimitotic Agents
Gout Suppressants
Pharmacologic Actions

Inflammation
Pathologic Processes
Therapeutic Uses
Syndrome
Acute Coronary Syndrome
Tubulin Modulators
Cardiovascular Diseases
Colchicine
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009