Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients
- Conditions
- Coronary Artery Disease
- Interventions
- Drug: EzetimibeDietary Supplement: Nutraceuticals
- Registration Number
- NCT01807078
- Lead Sponsor
- University of Roma La Sapienza
- Brief 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.
- 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 vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Study Population
Patients with coronary artery disease in stable conditions treated with percutaneous coronary intervention who have withdrawn statin treatment due to side effects
Randomization
Patients will be randomized to receive for 6 months either ezetimibe (10 mg/day) or a commercially available nutraceutical combined pill (1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- Angiographically-proven coronary artery disease
- Recent (<12 months) percutaneous coronary intervention
- Class I indication to receive statin treatment
- Previous (<12 months) withdrawn of a statin due to side effects
- Unwilling to receive treatment with an alternative statin
- Able to understand and willing to sign the informed consent form
• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ezetimibe Ezetimibe Patients will receive for 6 months ezetimibe (10 mg/day) Nutraceuticals Nutraceuticals Patients will receive for 6 months a commercially available nutraceutical combined pill (1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg
- Primary Outcome Measures
Name Time Method Reasons for treatment discontinuation 6 months Reasons for treatment discontinuation
- Secondary Outcome Measures
Name Time Method Effects on lipid profile 6 months Effects on cholesterol plasmatic levels
Trial Locations
- Locations (1)
Sapienza University
🇮🇹Rome, Lazio, Italy