Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients

Randomized Trial of Ezetimibe Versus nutraCeuticals in Statin-intoLerant patIents Treated With PercutaneouS Coronary Intervention

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01490229

Acronym

ECLIPSE

Enrollment

100

Registered

2011-12-12

Start date

2013-01-31

Completion date

2016-12-31

Last updated

2013-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

nutraceuticals, statin

Brief summary

Pharmacologic alternatives in statin-intolerant patients include ezetimibe and nutraceuticals (i.e. compounds derived from foods with cholesterol lowering actions). The investigators will compare the efficacy and tolerability of ezetimibe versus 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 versus a nutraceutical-based protocol in statin-intolerant patients treated with percutaneous coronary intervention.

Interventions

DRUGEzetimibe

os, 10 mg, once daily, 1 year

DRUGNutraceuticals

os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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 12 months) withdrawn of a statin due to side effects * Unwilling to receive treatment with an alternative statin * Able to understand and willing to sign the informed consent form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

Design outcomes

Primary

Measure	Time frame	Description
Evaluation of treatment tolerability	Up to 12 months	Reasons for treatment discontinuation

Secondary

Measure	Time frame	Description
Evaluation of drug effects on lipid and metabolic features	Up to 12 months	Effects on lipid profile (total cholesterol, LDL cholesterol, tryglicerides) and metabolic indexes (glucose levels, HOMA)

Countries

Italy

Contacts

Primary ContactFrancesco Pelliccia, MD

f.pelliccia@mclink.it+393483392006

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026