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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

Tracking Information
First Submitted Date  ICMJE March 15, 2014
First Posted Date  ICMJE March 18, 2014
Last Update Posted Date March 19, 2014
Study Start Date  ICMJE October 2006
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2014)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2014)		 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2014)		 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Plant Sterols Effect on Previous Statin Therapy
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Ezetimibe
    The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.
    Intervention: Drug: Ezetimibe
  • Experimental: Plant sterols
    The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks
    Intervention: Dietary Supplement: Plant sterols
  • 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
    Intervention: Other: Ezetimibe + plant sterols
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2014)		 47
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2008
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02089867
Other Study ID Numbers  ICMJE CEP 632
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jose Rocha Faria Neto, Pontifícia Universidade Católica do Paraná
Study Sponsor  ICMJE Jose Rocha Faria Neto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Jose R Faria Neto, PhD Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR)
PRS Account Pontifícia Universidade Católica do Paraná
Verification Date March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP