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

Sponsor
University of Roma La Sapienza (Other)
Overall Status
Unknown status
CT.gov ID
NCT01807078
Collaborator
(none)
200
Enrollment
1
Location
2
Arms
47
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

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 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Patients with coronary artery disease in stable conditions treated with percutaneous coronary intervention who have withdrawn statin treatment due to side effects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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Randomized Comparison of the CHOlesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant patientS - The CHOLESS Trial
Study Start Date :
Jan 1, 2014
Anticipated Primary Completion Date :
Dec 1, 2015
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Ezetimibe

Patients will receive for 6 months ezetimibe (10 mg/day)

Drug: Ezetimibe
10 mg p.d. of ezetimibe
Other Names:
  • Zetia

    		•
    Active Comparator: 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

    Dietary Supplement: Nutraceuticals
    1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg
    Other Names:
  • Choless
  • Fixlipid

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Reasons for treatment discontinuation [6 months]

      Reasons for treatment discontinuation

    Secondary Outcome Measures

    1. Effects on lipid profile [6 months]

      Effects on cholesterol plasmatic levels

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 90 Years
    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 CT

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sapienza University Rome Lazio Italy 00161

    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:
    NCT01807078
    Other Study ID Numbers:
    • 222-D-2013
    First Posted:
    Mar 8, 2013
    Last Update Posted:
    Mar 8, 2013
    Last Verified:
    Mar 1, 2013
    Keywords provided by Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
    Coronary artery disease
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Myocardial Ischemia
    Coronary Disease
    Ezetimibe

    Study Results

    No Results Posted as of Mar 8, 2013