Plant Sterols Effect on Previous Statin Therapy

• ClinicalTrials.gov Identifier: NCT02089867
• Recruitment Status: Completed
• First Posted: March 18, 2014
• Last Update Posted: March 19, 2014
• Sponsor: Jose Rocha Faria Neto
• Information provided by (Responsible Party): Jose Rocha Faria Neto, Pontifícia Universidade Católica do Paraná

Study Description

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

Condition or disease	Intervention/treatment	Phase
Coronary Artery Disease	Other: Ezetimibe + plant sterols; Drug: Ezetimibe; Dietary Supplement: Plant sterols	Phase 2; Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 47 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: October 2006
• Actual Primary Completion Date: August 2007
• Actual Study Completion Date: January 2008

Arms and Interventions

Arm	Intervention/treatment
Experimental: Ezetimibe; The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.	Drug: Ezetimibe; The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.
Experimental: Plant sterols; The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks	Dietary Supplement: Plant sterols; The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks
No Intervention: Control group; No additional therapy, statin maintenance
Experimental: 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	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

Outcome Measures

Primary Outcome Measures :

1. Decrease of LDL cholesterol levels due to plant sterols associated with ezetimibe. [ Time Frame: 6 weeks ]
   The primary end-point was the LDL cholesterol levels change after the plant sterols associated with ezetimibe from baseline up to 6 week treatment.

Secondary Outcome Measures :

1. 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. [ Time Frame: 6 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Brazil

Jose Rocha Faria Neto

Curitiba, Paraná, Brazil, 80215-901

Sponsors and Collaborators

Jose Rocha Faria Neto

Investigators

• Study Chair: Jose R Faria Neto, PhD; Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR)

More Information

• Responsible Party: Jose Rocha Faria Neto, Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR), Pontifícia Universidade Católica do Paraná
• ClinicalTrials.gov Identifier: NCT02089867
• Other Study ID Numbers: CEP 632
• First Posted: March 18, 2014
• Last Update Posted: March 19, 2014
• Last Verified: March 2014

Keywords provided by Jose Rocha Faria Neto, Pontifícia Universidade Católica do Paraná:

Ezetimibe; Plant sterol; Hydroxymethylglutaryl coenzyme A Reductase Inhibitors; Coronary artery disease; LDL-cholesterol

Additional relevant MeSH terms:

Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Ezetimibe; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents