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

Sponsor

University of Roma La Sapienza (Other)

Overall Status

Unknown status

CT.gov ID

NCT02001883

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Drug: Association low-dose statin and nutraceuticals	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Study Start Date :

Nov 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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).	Drug: Association low-dose statin and nutraceuticals Other Names: 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).
Active Comparator: Low-dose statin Patients will receive low-dose statin (10 to 20 mg/day of simvastatin or 5 to 10 mg/day atorvastatin)	Drug: Association low-dose statin and nutraceuticals Other Names: 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).

Arm

Intervention/Treatment

Active Comparator: 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).

Drug: Association low-dose statin and nutraceuticals

Other Names:

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).

Active Comparator: Low-dose statin

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

Drug: Association low-dose statin and nutraceuticals

Other Names:

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).

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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