NCT02001883

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

Randomized Trial of the Association Between Low-Dose Statins and Nutraceuticals in High-intEnsity Statin-intoleRant patiENts With Very High Risk Coronary Artery diseasE

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Association low-dose statin and nutraceuticals

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2013-12-05
• Last updated: 2013-12-05

Locations

1 site across 1 country: Italy