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

This study is currently recruiting participants.
Verified December 2013 by University of Roma La Sapienza
Sponsor:
Information provided by (Responsible Party):
Francesco Pelliccia, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT02001883
First received: November 24, 2013
Last updated: December 4, 2013
Last verified: December 2013
  Purpose

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 Intervention Phase
Coronary Artery Disease
Drug: Association low-dose statin and nutraceuticals
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Long-term adherence to study treatments [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]
    Satisfactory compliance (≥80%) in taking study drugs


Secondary Outcome Measures:
  • Number of participants with target LDL cholesterol [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Number of patients with at least a 50% reduction in LDL cholesterol as compared with baseline values at the end of the study period


Estimated Enrollment: 100
Study Start Date: November 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02001883

Locations
Italy
University Sapienza Recruiting
Rome, Please Select, Italy, 00161
Contact: FRANCESCO PELLICCIA       f.pelliccia@mclink.it   
Sponsors and Collaborators
University of Roma La Sapienza
  More Information

No publications provided

Responsible Party: Francesco Pelliccia, Assistant Professor, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT02001883     History of Changes
Other Study ID Numbers: 807/2013/D-2
Study First Received: November 24, 2013
Last Updated: December 4, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by University of Roma La Sapienza:
Coronary artery disease, nutraceuticals, statins

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Simvastatin
Atorvastatin
Policosanol
Red yeast rice
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Anticholesteremic Agents
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Hematologic Agents

ClinicalTrials.gov processed this record on April 15, 2014