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

Phase 4

• Conditions: Coronary Artery Disease
• Interventions: Drug: Association low-dose statin and nutraceuticals

• Registration Number: NCT02001883
• Lead Sponsor: University of Roma La Sapienza

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-24
• Status Verified: 2013-12
• Study First Submitted QC: 2013-12-04
• Last Update Submitted: 2013-12-04
• Study First Posted: 2013-12-05
• Last Update Posted: 2013-12-05
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Association low-dose statin and nutraceuticals	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).
Low-dose statin	Association low-dose statin and nutraceuticals	Patients will receive low-dose statin (10 to 20 mg/day of simvastatin or 5 to 10 mg/day atorvastatin)

Primary Outcome Measures

Name	Time	Method
Long-term adherence to study treatments	Up to 12 months	Satisfactory compliance (≥80%) in taking study drugs

Secondary Outcome Measures

Name	Time	Method
Number of participants with target LDL cholesterol	Up to 12 months	Number of patients with at least a 50% reduction in LDL cholesterol as compared with baseline values at the end of the study period

Trial Locations

Locations (1)

University Sapienza; 🇮🇹 Rome, Please Select, Italy