Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Ezetimibe
* Drug: Nutraceuticals


Participation Criteria
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Eligibility Criteria
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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 12 months) withdrawn of a statin due to side effects Unwilling to receive treatment with an alternative statin Able to understand and willing to sign the informed consent form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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ezetimibe<br>Patients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day) | Drug: Ezetimibe<br>* os, 10 mg, once daily, 1 year<br>* Other names: Zetia ®, Merck, USA;|
| Active Comparator: Nutraceuticals<br>Patients assigned to nutraceuticals will receive for 1 year 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg | Drug: Nutraceuticals<br>* os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year<br>* Other names: Armolipid Plus, Rottapharm Madaus, Italy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of treatment tolerability | Reasons for treatment discontinuation | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of drug effects on lipid and metabolic features | Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA) | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nutraceuticals, statin