Plant Sterols Effect on Previous Statin Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of plant sterols associated with ezetimibe in LDL-cholesterol levels in coronary patients previously on statin therapy

Detailed Description
-----------------
Background: Consumption of food products enriched with plant sterols and treatment with ezetimibe both reduce cholesterol absorption in the intestine by different mechanisms and effectively reduce LDL cholesterol (LDL-c) plasma levels. Although, the associated usage of ezetimibe to plants sterols in coronary patients not reaching recommended lipid levels despite the use of statins has not yet been demonstrated. Objectives: Evaluate if ezetimibe 10mg associated to plant sterols spread enriched with 2g of plant sterols in coronary patients not reaching recommended lipid levels despite the use of statins is able to reduce cholesterol levels after 6 week treatment. Methods: Prospective, open-label study with both male and female patients with stable coronary disease and LDL > 70mg/dL. Patients will be randomized for the following 6 week treatment: control group (CT) no additional statin therapy, ezetimibe group (EZ) 10 mg/day ezetimibe, plant sterol group (PS) spread enriched with 2g of plant sterols or ezetimibe+plant sterols group (EZ+PS) 10mg/day EZ + 2g PS. Anthropometric evaluations and laboratory exams (blood glucose test, total cholesterol, LDL-c, HDL-c, triglycerides, and C-Reactive Protein) will be performed in all groups at baseline and after the sixth week intervention.

Official Title
-----------------
A Randomized Open Label Trial to Assess the Effect of Plant Sterols Associated With Ezetimibe in LDL-cholesterol Levels in Coronary Patients Previously on Statin Therapy

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Other: Ezetimibe + plant sterols
* Drug: Ezetimibe
* Dietary Supplement: Plant sterols


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with previous myocardial infarction, stroke or coronary angiography demonstrating significant coronary disease. Subjects under statin treatment with a fixed dosage for the previous three months before randomization, and did not reached LDL less than 70mg/dl. Exclusion Criteria: Subjects already taking ezetimibe and/or plant sterols Younger than 18 years Presence of any contraindication to statin Pregnant women or breast-feeding women or Patients with previous history of statin hypersensibility

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ezetimibe<br>The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks. | Drug: Ezetimibe<br>* The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.<br>|
| Experimental: Plant sterols<br>The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks | Dietary Supplement: Plant sterols<br>* The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks<br>|
| No Intervention: Control group<br>No additional therapy, statin maintenance | |
| Experimental: Ezetimibe + plant sterols<br>The ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks | Other: Ezetimibe + plant sterols<br>* The ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease of LDL cholesterol levels due to plant sterols associated with ezetimibe. | The primary end-point was the LDL cholesterol levels change after the plant sterols associated with ezetimibe from baseline up to 6 week treatment. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any change of non-LDL-cholesterol, total cholesterol, high-density lipoprotein (HDL), very-low-density lipoprotein (VLDL), triglycerides levels, and changes in high sensitive C reactive protein (CRP) levels. | Secondary end points included any change of non-LDL-cholesterol, total cholesterol, high-density lipoprotein (HDL), very-low-density lipoprotein (VLDL), triglycerides levels, and changes in high sensitive C reactive protein (CRP) levels from baseline up to 6 week treatment. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ezetimibe, Plant sterol, Hydroxymethylglutaryl coenzyme A Reductase Inhibitors, Coronary artery disease, LDL-cholesterol