drugset / Trial / NCT01807078

Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients

NCT01807078

Phase 4 Unknown 200 enrolled University of Roma La Sapienza
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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. The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

Timeline

Start
2014-01
Primary completion
2015-12
Completion
2017-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ezetimibe Unknown 10 mg