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

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
Brazil | |
Jose Rocha Faria Neto | |
Curitiba, Paraná, Brazil, 80215-901 |
Study Chair: | Jose R Faria Neto, PhD | Professor in Medicine, Pontifícia Universidade Católica do Paraná (PUCPR) |
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 |
Ezetimibe Plant sterol Hydroxymethylglutaryl coenzyme A Reductase Inhibitors Coronary artery disease LDL-cholesterol |
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 |