Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients
ECLIPSE
Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 coronary-artery-disease
Started Jan 2013
Typical duration for phase_4 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 8, 2011
CompletedFirst Posted
Study publicly available on registry
December 12, 2011
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMarch 7, 2013
March 1, 2013
1.9 years
December 8, 2011
March 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of treatment tolerability
Reasons for treatment discontinuation
Up to 12 months
Secondary Outcomes (1)
Evaluation of drug effects on lipid and metabolic features
Up to 12 months
Study Arms (2)
Ezetimibe
ACTIVE COMPARATORPatients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day)
Nutraceuticals
ACTIVE COMPARATORPatients assigned to nutraceuticals will receive for 1 year 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg
Interventions
os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year
Eligibility Criteria
You may qualify if:
- 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 12 months) withdrawn of a statin due to side effects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
You may not qualify if:
- Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Raffaele Pisana
Rome, 00100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 8, 2011
First Posted
December 12, 2011
Study Start
January 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2016
Last Updated
March 7, 2013
Record last verified: 2013-03