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

Phase 4
Conditions
Coronary Artery Disease
Interventions
Drug: Ezetimibe
Dietary 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Patients with coronary artery disease in stable conditions treated with percutaneous coronary intervention who have withdrawn statin treatment due to side effects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
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12 months) withdrawn of a statin due to side effects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
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Exclusion Criteria

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EzetimibeEzetimibePatients will receive for 6 months ezetimibe (10 mg/day)
NutraceuticalsNutraceuticalsPatients 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
NameTimeMethod
Reasons for treatment discontinuation6 months

Reasons for treatment discontinuation

Secondary Outcome Measures
NameTimeMethod
Effects on lipid profile6 months

Effects on cholesterol plasmatic levels

Trial Locations

Locations (1)

Sapienza University

🇮🇹

Rome, Lazio, Italy

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