Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Background Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects. Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). It remains unknown, however, which of these two therapeutic approaches is more effective after PCI. Purpose The primary objective of this study is to compare the efficacy and tolerability of ezetimibe versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
os, 10 mg, once daily, 1 year
os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year
San Raffaele Pisana
Rome, Italy
RECRUITINGEvaluation of treatment tolerability
Reasons for treatment discontinuation
Time frame: Up to 12 months
Evaluation of drug effects on lipid and metabolic features
Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA)
Time frame: Up to 12 months
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