Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients
NCT ID: NCT01807078
Last Updated: 2013-03-08
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
200 participants
INTERVENTIONAL
2014-01-31
2017-12-31
Brief Summary
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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.
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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 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Patients with coronary artery disease in stable conditions treated with percutaneous coronary intervention who have withdrawn statin treatment due to side effects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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ezetimibe
Patients will receive for 6 months ezetimibe (10 mg/day)
Ezetimibe
10 mg p.d. of ezetimibe
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
Nutraceuticals
1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg
Interventions
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Ezetimibe
10 mg p.d. of ezetimibe
Nutraceuticals
1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg
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
18 Years
90 Years
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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Sapienza University
Rome, Lazio, Italy
Countries
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Facility Contacts
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Other Identifiers
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222-D-2013
Identifier Type: -
Identifier Source: org_study_id
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