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

Coronary Artery Disease Clinical Trial

— ADHERENCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02001883
• Other study ID #: 807/2013/D-2
• Status: Recruiting
• Phase: Phase 4
• First received: November 24, 2013
• Last updated: December 4, 2013
• Start date: November 2013
• Est. completion date: December 2015

Study information

• Verified date: December 2013
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Association low-dose statin and nutraceuticals

Locations

Country	Name	City	State
Italy	University Sapienza	Rome	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term adherence to study treatments	Satisfactory compliance (=80%) in taking study drugs	Up to 12 months	Yes
Secondary	Number of participants with target LDL cholesterol	Number of patients with at least a 50% reduction in LDL cholesterol as compared with baseline values at the end of the study period	Up to 12 months	No