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Plant Sterols Effect on Previous Statin Therapy

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

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.

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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


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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089867


Locations
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Brazil
Jose Rocha Faria Neto
Curitiba, Paraná, Brazil, 80215-901
Sponsors and Collaborators
Jose Rocha Faria Neto
Investigators
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Study Chair: Jose R Faria Neto, PhD Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR)
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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    Key Record Dates
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:
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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