Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients (ECLIPSE)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention|
- Evaluation of treatment tolerability [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]Reasons for treatment discontinuation
- Evaluation of drug effects on lipid and metabolic features [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA)
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Ezetimibe
Patients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day)
os, 10 mg, once daily, 1 year
Other Name: Zetia ®, Merck, USA
Active Comparator: Nutraceuticals
Patients assigned to nutraceuticals will receive for 1 year 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg
os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year
Other Name: Armolipid Plus, Rottapharm Madaus, Italy
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 versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490229
|Contact: Francesco Pelliccia, MDfirstname.lastname@example.org|
|San Raffaele Pisana||Recruiting|
|Rome, Italy, 00100|
|Contact: Giuseppe Marazzi, MD +39 335 8381320 email@example.com|