Clincosm LogoSign in Get a demo

ECLIPSE: Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Unknown status
CT.gov ID
NCT01490229
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
47
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

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 versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention
Study Start Date :
Jan 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ezetimibe

Patients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day)

Drug: Ezetimibe
os, 10 mg, once daily, 1 year
Other Names:
  • Zetia ®, Merck, USA

    		•
    Active Comparator: Nutraceuticals

    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
    os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year
    Other Names:
  • Armolipid Plus, Rottapharm Madaus, Italy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of treatment tolerability [Up to 12 months]

      Reasons for treatment discontinuation

    Secondary Outcome Measures

    1. Evaluation of drug effects on lipid and metabolic features [Up to 12 months]

      Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 San Raffaele Pisana Rome Italy 00100

    Sponsors and Collaborators

    • University of Roma La Sapienza

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
    ClinicalTrials.gov Identifier:
    NCT01490229
    Other Study ID Numbers:
    • 651/2011/D
    First Posted:
    Dec 12, 2011
    Last Update Posted:
    Mar 7, 2013
    Last Verified:
    Mar 1, 2013
    Keywords provided by Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
    nutraceuticals
    statin
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Ezetimibe

    Study Results

    No Results Posted as of Mar 7, 2013