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Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients (ECLIPSE)

Primary Purpose

Coronary Artery Disease

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Ezetimibe
Nutraceuticals
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring nutraceuticals, statin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 12 months) withdrawn of a statin due to side effects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

Sites / Locations

  • San Raffaele PisanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ezetimibe

Nutraceuticals

Arm Description

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

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

Outcomes

Primary Outcome Measures

Evaluation of treatment tolerability
Reasons for treatment discontinuation

Secondary Outcome Measures

Evaluation of drug effects on lipid and metabolic features
Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA)

Full Information

First Posted
December 8, 2011
Last Updated
March 6, 2013
Sponsor
University of Roma La Sapienza
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1. Study Identification

Unique Protocol Identification Number
NCT01490229
Brief Title
Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients
Acronym
ECLIPSE
Official Title
Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Roma La Sapienza

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
nutraceuticals, statin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ezetimibe
Arm Type
Active Comparator
Arm Description
Patients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day)
Arm Title
Nutraceuticals
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Ezetimibe
Other Intervention Name(s)
Zetia ®, Merck, USA
Intervention Description
os, 10 mg, once daily, 1 year
Intervention Type
Drug
Intervention Name(s)
Nutraceuticals
Other Intervention Name(s)
Armolipid Plus, Rottapharm Madaus, Italy
Intervention Description
os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year
Primary Outcome Measure Information:
Title
Evaluation of treatment tolerability
Description
Reasons for treatment discontinuation
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Evaluation of drug effects on lipid and metabolic features
Description
Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA)
Time Frame
Up to 12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Pelliccia, MD
Phone
+393483392006
Email
f.pelliccia@mclink.it
Facility Information:
Facility Name
San Raffaele Pisana
City
Rome
ZIP/Postal Code
00100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Marazzi, MD
Phone
+39 335 8381320
Email
giuseppe.marazzi@yahoo.com

12. IPD Sharing Statement

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Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients

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