Plant Sterols Effect on Previous Statin Therapy

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089867
• Other study ID #: CEP 632
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 15, 2014
• Last updated: March 17, 2014
• Start date: October 2006
• Est. completion date: January 2008

Study information

• Verified date: March 2014
• Source: Pontifícia Universidade Católica do Paraná
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: January 2008
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Ezetimibe + plant sterols
The ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks

Drug:
• Ezetimibe
The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.

Dietary Supplement:
• Plant sterols
The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks

Locations

Country	Name	City	State
Brazil	Jose Rocha Faria Neto	Curitiba	Paraná

Sponsors (1)

Lead Sponsor	Collaborator
Jose Rocha Faria Neto

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No