Status:
UNKNOWN
Colchicine for Acute Coronary Syndromes
Lead Sponsor:
Maria Vittoria Hospital
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
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...
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 sy...
Eligibility Criteria
Inclusion
- \>18years
- Acute coronary syndrome (unstable angina or acute myocardial infarction)
- Life expectancy\> 2 years
- Absence of contraindications to colchicine
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2016
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT01906749
Start Date
June 1 2013
End Date
June 1 2016
Last Update
July 24 2013
Active Locations (3)
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1
Cardiology Dpt.
Rivoli, Torino, Italy, 10098
2
Cardiology Dpt.Maria Vittoria Hospital
Torino, Torino, Italy, 10141
3
Cardiology Dpt.San Giovanni Bosco Hospital
Torino, Torino, Italy, 10141