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

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Roma La Sapienza
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Policosanol; Red yeast rice; Simvastatin

Criteria

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