Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation

Phase 4 Study on Effect of Ezetimibe on Platelet Aggregation and LDL Tendency to Peroxidation In Hypercholesterolemic Patients on Simvastatin

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00466401

Enrollment

Registered

2007-04-27

Start date

2005-02-28

Completion date

2007-08-31

Last updated

2013-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Brief summary

The aim of our study is to Estimate the reduction of LDL by ezetimibe in hypercholesterolemic patients on simvastatin.Investigate the effect of LDL lowering by ezetimibe on platelet activity and LDL tendency to peroxidation in hypercholesterolemic patients on simvastatin therapy The hypothesis is that: 1. LDL lowering by ezetimibe on-top of simvastatin in patients on fixed dose of simvastatin can reduce platelet aggregation, due to the potential decreasing of cholesterol content in the platelet membranes. 2. LDL lowering by ezetimibe can lower LDL tendency to peroxidation.

Interventions

DRUGSimvastatin

DRUGEzetimibe

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Hypercholesterolemic patients on stable simvastatin dose for at least one month. 2. Age ≥18 years on stable AHA step 1 diet. 3. Patients without CHD or with one risk factors ; LDL \> 130 mg/dL and for Patients with CHD or CHD risk equivalent(clinical manifestations of non-coronary forms of atherosclerotic disease) or with 2 risk f actors (cigarette smoking, hypertension (BP ≥140/90 mm Hg or on antihypertensive medication), low HDL cholesterol (\<40 mg/dL), family history of premature CHD;LDL\>100 mg/dL 4. Patients 'on at least simvastatin treatment of 20 mg per day. 5. CPK, ALT and AST \< 1.5 X upper limit of normal at baseline.

Exclusion criteria

1. Women currently receiving cyclical hormones. 2. Treatment with psyllium, other fiber based laxatives, phytosterol margarines, or other OTCs that affect serum lipids, unless treated with a stable regimen for \> 6 weeks and the patient agrees to continue this regimen for the duration of the trial. 3. Oral corticosteroids unless used as replacement therapy for pituitary/adrenal disease and a stable regimen for at least 6 weeks. 4. Lipid lowering agents including fish oils and QUESTRAN taken within 6 weeks. 5. Active coronary heart disease: unstable angina, acute myocardial infarction, CABG or PTCA within the last 3 months. 6. Women with childbearing potential unless on safe contraception. 7. Psychiatric disease with defect in judgement. 8. Severe renal or hepatic disease. 9. Uncontrolled hypo- or hyperthyroidism. 10. Contraindication for ezetimibe or simvastatin treatment. The patients will continue on their treatment with simvastatin for 6 weeks, and then the patients will be treated by the same dose of simvastatin combined with ezetimibe 10 mg/day for other 6 weeks.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026