Cholesterol-lowering Effects of nutraceuticaLs Versus Eze... | NCT01807078

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

NCT01807078

Sponsor

University of Roma La Sapienza

Status

Unknown status

Last Update Posted

Mar 8, 2013Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Coronary Artery Disease

Interventions

Ezetimibe
Nutraceuticals

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2015Estimated

Completion Date

Dec 2017Estimated

First Submitted Date

Mar 6, 2013

First Submission Date that Met QC Criteria

Mar 6, 2013

First Posted Date

Mar 8, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 6, 2013

Last Update Posted Date

Mar 8, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Francesco Pelliccia, Assistant Professor, University of Roma La SapienzaPrincipal Investigator

Lead Sponsor

University of Roma La SapienzaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ezetimibe	Active Comparator	Patients will receive for 6 months ezetimibe (10 mg/day)	Drug: Ezetimibe
Nutraceuticals	Active Comparator	Patients will receive for 6 months a commercially available nutraceutical combined pill (1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg	Dietary Supplement: Nutraceuticals

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ezetimibe	Drug	10 mg p.d. of ezetimibe	Ezetimibe	Zetia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reasons for treatment discontinuation	Reasons for treatment discontinuation	6 months

Secondary Outcomes

Measure	Description	Time Frame
Effects on lipid profile	Effects on cholesterol plasmatic levels	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sapienza University		Rome	Lazio	00161	Italy

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069438	Ezetimibe
D019587	Dietary Supplements

Ancestor Terms

ID	Term
D001384	Azetidines
D001385	Azetines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided