Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients
NCT ID: NCT01490229
Last Updated: 2013-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
100 participants
INTERVENTIONAL
2013-01-31
2016-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ezetimibe
Patients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day)
Ezetimibe
os, 10 mg, once daily, 1 year
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
Nutraceuticals
os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year
Interventions
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Ezetimibe
os, 10 mg, once daily, 1 year
Nutraceuticals
os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 12 months) withdrawn of a statin due to side effects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
ALL
No
Sponsors
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University of Roma La Sapienza
OTHER
Responsible Party
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Francesco Pelliccia
Assistant Professor
Locations
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San Raffaele Pisana
Rome, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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651/2011/D
Identifier Type: -
Identifier Source: org_study_id
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