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Colchicine for Acute Coronary Syndromes (COACS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2013 by Massimo Imazio, Maria Vittoria Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01906749
First Posted: July 24, 2013
Last Update Posted: July 24, 2013
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.
Information provided by (Responsible Party):
Massimo Imazio, Maria Vittoria Hospital
  Purpose
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 Intervention Phase
Acute Coronary Syndrome Drug: Colchicine Drug: Placebo Phase 4

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Massimo Imazio, Maria Vittoria Hospital:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
Study Start Date: June 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Active Comparator: Colchicine
Colchicine 0.5mg once daily for 24 months
Drug: Colchicine
0.5mg once daily orally

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
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
Contact: Massimo Imazio, MD +39011439 ext 3391 massimo_imazio@yahoo.it

Locations
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
Study Chair: Massimo Imazio, MD Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy
  More Information

Responsible Party: Massimo Imazio, MD, Maria Vittoria Hospital
ClinicalTrials.gov Identifier: NCT01906749     History of Changes
Other Study ID Numbers: 27/06/13
2013-001415-78 ( EudraCT Number )
First Submitted: July 21, 2013
First Posted: July 24, 2013
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:
Syndrome
Acute Coronary 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