Randomized Comparison of the CHOlesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant patientS - The CHOLESS Trial
Overview
- Phase
- Phase 4
- Intervention
- Ezetimibe
- Conditions
- Coronary Artery Disease
- Sponsor
- University of Roma La Sapienza
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Reasons for treatment discontinuation
- Last Updated
- 13 years ago
Overview
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Patients with coronary artery disease in stable conditions treated with percutaneous coronary intervention who have withdrawn statin treatment due to side effects Randomization Patients will be randomized to receive for 6 months either ezetimibe (10 mg/day) or a commercially available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).
Investigators
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza
Eligibility Criteria
Inclusion Criteria
- •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12 months) withdrawn of a statin due to side effects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
Exclusion Criteria
- •Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
Arms & Interventions
Ezetimibe
Patients will receive for 6 months ezetimibe (10 mg/day)
Intervention: Ezetimibe
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
Intervention: Nutraceuticals
Outcomes
Primary Outcomes
Reasons for treatment discontinuation
Time Frame: 6 months
Reasons for treatment discontinuation
Secondary Outcomes
- Effects on lipid profile(6 months)