Cholesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant Patients

Coronary Artery Disease Clinical Trial

— CHOLESS  

Official title:

Randomized Comparison of the CHOlesterol-lowering Effects of nutraceuticaLs Versus Ezetimibe in Statin-intolerant patientS - The CHOLESS Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01807078
• Other study ID #: 222-D-2013
• Status: Not yet recruiting
• Phase: Phase 4
• First received: March 6, 2013
• Last updated: March 6, 2013
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: March 2013
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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Patients with coronary artery disease in stable conditions treated with percutaneous coronary intervention who have withdrawn statin treatment due to side effects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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Ezetimibe
10 mg p.d. of ezetimibe

Dietary Supplement:
• Nutraceuticals
1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg

Locations

Country	Name	City	State
Italy	Sapienza University	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reasons for treatment discontinuation	Reasons for treatment discontinuation	6 months	Yes
Secondary	Effects on lipid profile	Effects on cholesterol plasmatic levels	6 months	No