Coronary Artery Disease
Conditions
Keywords
Coronary artery disease
Brief summary
Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects. Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). It remains unknown, however, which of these two therapeutic approaches is more effective after PCI. The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Detailed description
Background Treatment with statins has a class I indication after percutaneous coronary intervention (PCI), but is often discontinued by patients due to side effects. Pharmacologic alternatives shown to be useful after PCI include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). It remains unknown, however, which of these two therapeutic approaches is more effective after PCI. Purpose The primary objective of this study is to compare the efficacy and tolerability of ezetimibe vs. a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention. Study Population Patients with coronary artery disease in stable conditions treated with percutaneous coronary intervention who have withdrawn statin treatment due to side effects Randomization Patients will be randomized to receive for 6 months either ezetimibe (10 mg/day) or a commercially available nutraceutical combined pill (1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg).
Interventions
DRUGEzetimibe
10 mg p.d. of ezetimibe
DIETARY_SUPPLEMENTNutraceuticals
1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg
Sponsors
University of Roma La Sapienza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
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 * Previous (\<12 months) withdrawn of a statin due to side effects * Unwilling to receive treatment with an alternative statin * Able to understand and willing to sign the informed consent form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 |
|---|---|---|
| Reasons for treatment discontinuation | 6 months | Reasons for treatment discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effects on lipid profile | 6 months | Effects on cholesterol plasmatic levels |
Countries
Italy
Outcome results
None listed