Clinical trial NCT02089867: Plant Sterols Effect on Previous Statin Therapy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Keywords: Ezetimibe
Plant sterol
Hydroxymethylglutaryl coenzyme A Reductase Inhibitors
Coronary artery disease
LDL-cholesterol
Lead sponsor: Pontifícia Universidade Católica do Paraná
Sponsor class: OTHER
First posted: 2014-03-18
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Decrease of LDL cholesterol levels due to plant sterols associated with ezetimibe.
timeFrame: 6 weeks
Secondary outcomes:
measure: 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.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Jose Rocha Faria Neto
state: Paraná
Study officials:
affiliation: Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR)
name: Jose R Faria Neto, PhD
role: STUDY_CHAIR
References: