Plant Sterols Effect on Previous Statin Therapy
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
1 other identifier
interventional
47
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 coronary-artery-disease
Started Oct 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 15, 2014
CompletedFirst Posted
Study publicly available on registry
March 18, 2014
CompletedMarch 19, 2014
March 1, 2014
10 months
March 15, 2014
March 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (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.
6 weeks
Study Arms (4)
Ezetimibe
EXPERIMENTALThe ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.
Plant sterols
EXPERIMENTALThe plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks
Control group
NO INTERVENTIONNo additional therapy, statin maintenance
Ezetimibe + plant sterols
EXPERIMENTALThe ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks
Interventions
The ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks
The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jose Rocha Faria Neto
Curitiba, Paraná, 80215-901, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jose R Faria Neto, PhD
Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR)
Study Record Dates
First Submitted
March 15, 2014
First Posted
March 18, 2014
Study Start
October 1, 2006
Primary Completion
August 1, 2007
Study Completion
January 1, 2008
Last Updated
March 19, 2014
Record last verified: 2014-03