NCT01490229

Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients

Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Ezetimibe	os, 10 mg, once daily, 1 year
DRUG	Nutraceuticals	os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-12-01
• Completion: 2016-12-01
• First posted: 2011-12-12
• Last updated: 2013-03-07

Locations

1 site across 1 country: Italy