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

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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Association low-dose statin and nutraceuticals

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Please Select
    • Rome, Please Select, Italy, 00161
      • Recruiting
      • University Sapienza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long-term adherence to study treatments	Satisfactory compliance (≥80%) in taking study drugs	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2014
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: November 24, 2013
• First Submitted That Met QC Criteria: December 4, 2013
• First Posted (ESTIMATE): December 5, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 5, 2013
• Last Update Submitted That Met QC Criteria: December 4, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Coronary artery disease, nutraceuticals, statins
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Platelet Aggregation Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin; Simvastatin; Policosanol; Red yeast rice
• Other Study ID Numbers: 807/2013/D-2