Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
500 participants
INTERVENTIONAL
2013-06-30
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Colchicine
Colchicine 0.5mg once daily for 24 months
Colchicine
0.5mg once daily orally
Interventions
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Colchicine
0.5mg once daily orally
Placebo
Eligibility Criteria
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Inclusion Criteria
* Acute coronary syndrome (unstable angina or acute myocardial infarction)
* Life expectancy\> 2 years
* Absence of contraindications to colchicine
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Maria Vittoria Hospital
OTHER
Responsible Party
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Massimo Imazio
MD
Principal Investigators
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Massimo Imazio, MD
Role: STUDY_CHAIR
Cardiology Dpt.Maria Vittoria Hospital, Torino, Italy
Locations
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Cardiology Dpt.
Rivoli, Torino, Italy
Cardiology Dpt.Maria Vittoria Hospital
Torino, Torino, Italy
Cardiology Dpt.San Giovanni Bosco Hospital
Torino, Torino, Italy
Countries
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Central Contacts
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Facility Contacts
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Ferdinando Varbella, MD
Role: primary
Alessandra Chinaglia, MD
Role: primary
Patrizia Noussan, MD
Role: primary
References
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Silvis MJM, Demkes EJ, Fiolet ATL, Dekker M, Bosch L, van Hout GPJ, Timmers L, de Kleijn DPV. Immunomodulation of the NLRP3 Inflammasome in Atherosclerosis, Coronary Artery Disease, and Acute Myocardial Infarction. J Cardiovasc Transl Res. 2021 Feb;14(1):23-34. doi: 10.1007/s12265-020-10049-w. Epub 2020 Jul 9.
Other Identifiers
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2013-001415-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
27/06/13
Identifier Type: -
Identifier Source: org_study_id
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