Phase
Condition
Coronary Artery Disease
Myocardial Ischemia
Inflammation
Treatment
Colchicine
Atorvastatin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
non-ST elevation acute coronary syndrome;
≥ 18 years;
statin-naive.
Exclusion
Exclusion Criteria:
prior statin therapy and/or colchicine treatment;
known allergy or hypersensitivity to colchicine or statins;
current treatment with potent inhibitors of CYP3A4 or P-glycoprotein (eg.,Cyclosporin, antiretroviral drugs, antimycotics, erythromicin and clarythromycin);
previous or scheduled administration of any immunosuppressive therapy;
known active malignancy;
severe kidney disease (creatinine > 3 mg/dl or dialysis)
severe liver disease (ALT and/or AST, > double ref. normal values in case of (a)total bilirubin > double ref. normal values, or (b) alteration in coagulation (INR> 1,5);
severe heart failure (NYHA class ≥ 3 or cardiogenic shock) at hospital presentation;
severe acute or chronic gastro-intestinal disease (nausea, vomiting, diarrhea,malabsorption disease, malnutrition);
pregnancy or lactation;
current COVID-19 or other infectious disease;
refusal of consent.
Study Design
Study Description
Connect with a study center
Gaia Chiara Selvaggia Magnaghi
Pescia, 59100
ItalySite Not Available
Marco Comeglio
Pistoia, 51100
ItalySite Not Available
Anna Toso
Prato, 59100
ItalySite Not Available
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