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Low-dose Statins and Nutraceuticals in High-intensity Statin-intolerant Patients

NCT ID: NCT02001883

Last Updated: 2013-12-05

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-12-31

Brief Summary

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The primary objective of this study is to compare the efficacy and tolerability of low-dose statin therapy vs. the association between a low-dose statin and a nutraceutical-based protocol in high-dose statin-intolerant patients with coronary artery disease deemed to be at high-risk.

Detailed Description

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Several clinical trials have shown that in patients with atherosclerotic cardiovascular disease, reduction of low-density lipoprotein (LDL) level with a beta-hydroxy-beta-methylglutaryl coenzyme A reductase inhibitor (ie, statin) is associated with significant reductions in both mortality rate and major cardiac events.

Accordingly, current guidelines recommend that high-intensity statin therapy-such as rosuvastatin 20 to 40 mg or atorvastatin 80 mg-should be used to achieve at least a 50% reduction in LDL cholesterol unless otherwise contraindicated.

In real world clinical practice, however, high-intensity statin treatment is often discontinued by patients due to side effects. As alternatives, nonstatin drugs, such as ezetimibe, are often prescribed in association with moderate-to-low intensity statin.

It remains unknown, however, whether the association between moderate-to-low intensity statin therapy and and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions) can have a therapeutic role in high-intensity statin-intolerant patients.

Conditions

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Coronary Artery Disease

Keywords

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Coronary artery disease, nutraceuticals, statins

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Association low-dose statin and nutraceuticals

Patients will receive the association between low-dose statin (10 to 20 mg/day of simvastatin or 5 to 10 mg/day atorvastatin) and a commercially available nutraceutical combined pill (1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg).

Group Type ACTIVE_COMPARATOR

Association low-dose statin and nutraceuticals

Intervention Type DRUG

Low-dose statin

Patients will receive low-dose statin (10 to 20 mg/day of simvastatin or 5 to 10 mg/day atorvastatin)

Group Type ACTIVE_COMPARATOR

Association low-dose statin and nutraceuticals

Intervention Type DRUG

Interventions

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Association low-dose statin and nutraceuticals

Intervention Type DRUG

Other Intervention Names

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10 to 20 mg/day of simvastatin 5 to 10 mg/day atorvastatin nutraceutical combined pill (1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg).

Eligibility Criteria

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Inclusion Criteria

* Angiographically-proven coronary artery disease
* Recent (\<12 months) percutaneous coronary intervention
* Class I indication to receive statin treatment to achieve the LDL cholesterol goal of \<70 mg/dL
* 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 CT
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Francesco Pelliccia

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Sapienza

Rome, Please Select, Italy

Site Status RECRUITING

Countries

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Italy

Facility Contacts

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FRANCESCO PELLICCIA

Role: primary

Other Identifiers

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807/2013/D-2

Identifier Type: -

Identifier Source: org_study_id