Coronary Artery DiseasePhase 2/3NCT02089867
Plant Sterols Effect on Previous Statin Therapy
A Phase 2/3 study testing Ezetimibe + plant sterols, Ezetimibe and Plant sterols in people with Coronary Artery Disease, run by Jose Rocha Faria Neto at 1 site in Brazil.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Ezetimibe + plant sterols, Ezetimibe and Plant sterols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2006to Jan 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Coronary Artery Disease
- Being tested
- Ezetimibe + plant sterols, Ezetimibe, Plant sterols
- Keywords
- Ezetimibe, Plant sterol, Hydroxymethylglutaryl coenzyme A Reductase Inhibitors, Coronary artery disease, LDL-cholesterol
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe + plant sterolsOther
The ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks
EzetimibeDrug
The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.
Plant sterolsDietary supplement
The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ezetimibe | Experimental | The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks. Receives: Drug: Ezetimibe |
| Plant sterols | Experimental | The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks Receives: Dietary Supplement: Plant sterols |
| Control group | No intervention | No additional therapy, statin maintenance |
| Ezetimibe + plant sterols | Experimental | The ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks Receives: Other: Ezetimibe + plant sterols |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startOct 2006
- Primary completionAug 2007
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jose Rocha Faria Neto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jose Rocha Faria Neto, Pontifícia Universidade Católica do Paraná
- Investigators
- Jose R Faria Neto, PhD, Study chair, Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089867
- Sponsor's protocol ID
- CEP 632
- Status last verified
- Mar 2014
- First submitted
- 15 Mar 2014
- Last updated
- 19 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02089867
- Acronym / sponsor ID
- CEP 632
- Conditions
- Coronary Artery Disease
- Keywords
- Ezetimibe, Plant sterol, Hydroxymethylglutaryl coenzyme A Reductase Inhibitors, Coronary artery disease, LDL-cholesterol
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Jose Rocha Faria NetoUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ezetimibe | Experimental | Drug: EzetimibeThe ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks. |
| Plant sterols | Experimental | Dietary Supplement: Plant sterolsThe plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks |
| Control group | No intervention | –No additional therapy, statin maintenance |
| Ezetimibe + plant sterols | Experimental | Other: Ezetimibe + plant sterolsThe ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ezetimibe + plant sterolsThe 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 |
| EzetimibeThe ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks. | Drug | Ezetimibe |
| Plant sterolsThe plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks | Dietary supplement | Plant sterols |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose R Faria Neto, PhD study chair
Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ezetimibe + plant sterols, Ezetimibe and Plant sterols in people with Coronary Artery Disease, run by Jose Rocha Faria Neto at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease of LDL cholesterol levels due to plant sterols associated with ezetimibe. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2014.