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

NCT01807078 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2013-03-08

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Ezetimibe

10 mg p.d. of ezetimibe

DIETARY_SUPPLEMENT

Nutraceuticals

1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg

Sponsors & Collaborators

  • University of Roma La Sapienza

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-12-31
Completion
2017-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01807078 on ClinicalTrials.gov