Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients (ECLIPSE)
|ClinicalTrials.gov Identifier: NCT01490229|
Recruitment Status : Unknown
Verified March 2013 by Francesco Pelliccia, University of Roma La Sapienza.
Recruitment status was: Recruiting
First Posted : December 12, 2011
Last Update Posted : March 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Drug: Ezetimibe Drug: Nutraceuticals||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention|
|Study Start Date :||January 2013|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2016|
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
- Evaluation of treatment tolerability [ Time Frame: Up to 12 months ]Reasons for treatment discontinuation
- Evaluation of drug effects on lipid and metabolic features [ Time Frame: Up to 12 months ]Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|