Ezetimibe Versus Nutraceuticals in Statin-intolerant Patients (ECLIPSE)

University of Roma La Sapienza

Status and phase: Unknown; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Ezetimibe; Drug: Nutraceuticals

Study type: Interventional

Funder types: Other

Identifiers

NCT01490229

651/2011/D

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Volunteers: No 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 12 months) withdrawn of a statin due to side effects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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Ezetimibe

Active Comparator group

Description:

Patients assigned to ezetimibe will receive for 1 year ezetimibe (10 mg/day)

Treatment:

Drug: Ezetimibe

Nutraceuticals

Active Comparator group

Description:

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

Treatment:

Drug: Nutraceuticals