Colchicine for Acute Coronary Syndromes (COACS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01906749
Recruitment Status : Unknown
Verified July 2013 by Massimo Imazio, Maria Vittoria Hospital.
Recruitment status was:  Recruiting
First Posted : July 24, 2013
Last Update Posted : July 24, 2013
Information provided by (Responsible Party):
Massimo Imazio, Maria Vittoria Hospital

July 21, 2013
July 24, 2013
July 24, 2013
June 2013
June 2016   (Final data collection date for primary outcome measure)
Overall mortality, new acute coronary syndrome, and ischemic stroke. [ Time Frame: 24 months ]
Same as current
No Changes Posted
  • Mortality [ Time Frame: 24 months ]
    Secondary outcome measures will contain each issue of the combined primary endpoint as separate outcome.
  • New acute coronary syndrome (unstable angina and myocardial infarction) [ Time Frame: 24 months ]
  • Ischemic Stroke [ Time Frame: 24 months ]
Same as current
Not Provided
Not Provided
Colchicine for Acute Coronary Syndromes
Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial.
Multicenter, double blind, randomized trial to assess the effect of low-dose colchicine (0.5mg/day) on overall mortality, new coronary syndromes, and ischemic stroke at 2 years after an acute coronary syndrome. The study hypothesis is that colchicine may reduce the specified combined endpoint from 16% to 7-8% at a 2-years follow-up.
Multicenter, double-blind randomized trial to evaluate the efficacy of low dose colchicine (0.5mg once daily for 2 years) to reduce the incidence of subsequent overall mortality, new acute coronary syndromes, and ischemic stroke in patients admitted for an acute coronary syndrome.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Colchicine
    0.5mg once daily orally
  • Drug: Placebo
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Colchicine
    Colchicine 0.5mg once daily for 24 months
    Intervention: Drug: Colchicine
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2016
June 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • >18years
  • Acute coronary syndrome (unstable angina or acute myocardial infarction)
  • Life expectancy> 2 years
  • Absence of contraindications to colchicine

Exclusion Criteria:

  • Colchicine treatment for any cause
  • Severe liver disease
  • Renal insufficiency with creatinine>150mmol/l or creatinine clearance<30ml/min/1.73m2
  • Known cancer
  • Chronic inflammatory bowel disease
  • treatment with cyclosporine
  • allergy or hypersensitivity to colchicine
  • pregnancy or lactating woman or woman with childbearing potential without valid contraception
Sexes Eligible for Study: All
18 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
2013-001415-78 ( EudraCT Number )
Not Provided
Not Provided
Massimo Imazio, Maria Vittoria Hospital
Maria Vittoria Hospital
Not Provided
Study Chair: Massimo Imazio, MD Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy
Maria Vittoria Hospital
July 2013

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