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Colchicine for Acute Coronary Syndromes (COACS)

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ClinicalTrials.gov 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
Sponsor:
Information provided by (Responsible Party):
Massimo Imazio, Maria Vittoria Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Colchicine Drug: Placebo Phase 4

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Colchicine for Acute Coronary Syndromes. A Multicenter Double Blind Randomized Trial.
Study Start Date : June 2013
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Active Comparator: Colchicine
Colchicine 0.5mg once daily for 24 months
 Drug: Colchicine
0.5mg once daily orally


Outcome Measures
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Primary Outcome Measures :
  1. Overall mortality, new acute coronary syndrome, and ischemic stroke. [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 24 months ]
    Secondary outcome measures will contain each issue of the combined primary endpoint as separate outcome.

  2. New acute coronary syndrome (unstable angina and myocardial infarction) [ Time Frame: 24 months ]
  3. Ischemic Stroke [ Time Frame: 24 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01906749


Contacts
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Contact: Massimo Imazio, MD +39011439 ext 3391 massimo_imazio@yahoo.it

Locations
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Italy
Cardiology Dpt. Not yet recruiting
Rivoli, Torino, Italy, 10098
Contact: Ferdinando Varbella, MD    011 95511      
Principal Investigator: Ferdinando Varbella, MD         
Cardiology Dpt.Maria Vittoria Hospital Recruiting
Torino, Italy, 10141
Contact: Alessandra Chinaglia, MD    +39011439 ext 3226      
Sub-Investigator: Luisella Coda, MD         
Principal Investigator: Alessandra Chinaglia, MD         
Cardiology Dpt.San Giovanni Bosco Hospital Recruiting
Torino, Italy, 10141
Contact: Patrizia Noussan, MD    +39 240 ext 2285      
Principal Investigator: Patrizia Noussan, MD         
Sponsors and Collaborators
Maria Vittoria Hospital
Investigators
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Study Chair: Massimo Imazio, MD Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Massimo Imazio, MD, Maria Vittoria Hospital
ClinicalTrials.gov Identifier: NCT01906749    
Other Study ID Numbers: 27/06/13
2013-001415-78 ( EudraCT Number )
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: July 24, 2013
Last Verified: July 2013
Keywords provided by Massimo Imazio, Maria Vittoria Hospital:
Acute coronary syndrome
Colchicine
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
 Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents