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Colchicine for Acute Coronary Syndromes (COACS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Maria Vittoria Hospital
Sponsor:
Information provided by (Responsible Party):
Massimo Imazio, Maria Vittoria Hospital
ClinicalTrials.gov Identifier:
NCT01906749
First received: July 21, 2013
Last updated: July 23, 2013
Last verified: July 2013

July 21, 2013
July 23, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01906749 on ClinicalTrials.gov Archive Site
  • Mortality [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Ischemic Stroke [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Drug: Colchicine
    0.5mg once daily orally
  • Drug: Placebo
  • Placebo Comparator: Placebo
    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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
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
Both
18 Years to 90 Years
No
Contact: Massimo Imazio, MD +39011439 ext 3391 massimo_imazio@yahoo.it
Italy
 
NCT01906749
27/06/13, 2013-001415-78
Yes
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