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Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients (ECLIPSE)

This study is currently recruiting participants.
Verified March 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01490229
First received: December 8, 2011
Last updated: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention Phase
Coronary Artery Disease
 Drug: Ezetimibe
Drug: Nutraceuticals
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention

Resource links provided by NLM:

Drug Information available for: Ezetimibe
U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Evaluation of treatment tolerability [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Reasons for treatment discontinuation


Secondary Outcome Measures:
  • Evaluation of drug effects on lipid and metabolic features [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA)


Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Armolipid Plus, Rottapharm Madaus, Italy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490229

Contacts
Contact: Francesco Pelliccia, MD +393483392006 f.pelliccia@mclink.it

Locations
Italy
San Raffaele Pisana Recruiting
Rome, Italy, 00100
Contact: Giuseppe Marazzi, MD     +39 335 8381320     giuseppe.marazzi@yahoo.com    
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01490229     History of Changes
Other Study ID Numbers: 651/2011/D
Study First Received: December 8, 2011
Last Updated: March 6, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by University of Roma La Sapienza:
nutraceuticals
statin

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013