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Completed

NCT Number: NCT00754819

Targeting Inflammation in Acute Coronary Syndrome Using Colchicine

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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Hamilton General Hospital

Hamilton, Ontario, L8L2X2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Colchicine

Drug

1mg once daily

Placebo

Drug

1 capsule daily

Primary outcomes

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

    Time frame: 30 days

Secondary outcomes

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

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Official study title

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

Acronym: COOL

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 18, 2008
Registry last updated
Oct 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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