Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, nutraceuticals, statins
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.
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.
Interventions
DRUGAssociation low-dose statin and nutraceuticals
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term adherence to study treatments | Up to 12 months | Satisfactory compliance (≥80%) in taking study drugs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Outcome results
None listed