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

NCT02001883 | Unknown Phase 4

• 1 other identifier: 807/2013/D-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

Coronary artery disease, nutraceuticals, statins

Outcome Measures

Primary Outcomes (1)

• Long-term adherence to study treatments

  Satisfactory compliance (≥80%) in taking study drugs

  Up to 12 months

Secondary Outcomes (1)

• Number of participants with target LDL cholesterol

  Up to 12 months

Study Arms (2)

Association low-dose statin and nutraceuticals

ACTIVE COMPARATOR

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

Low-dose statin

ACTIVE COMPARATOR

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

Interventions

Association low-dose statin and nutraceuticals DRUG

Also known as: 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).

Association low-dose statin and nutraceuticals; Low-dose statin

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

University Sapienza

Rome, Please Select, 00161, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Association; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Dietary Supplements; Simvastatin; Atorvastatin; policosanol; Berberine

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Psychotherapeutic Processes; Psychotherapy; Behavioral Disciplines and Activities; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 24, 2013
• First Posted: December 5, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: December 5, 2013

Record last verified: 2013-12

Locations

IT (1)