Effect of Ezetimibe on Oxidized Low-density Lipoprotein (LDL) Cholesterol

Hotel Dieu de France Hospital

Status and phase: Completed; Phase 4

Conditions: Coronary Artery Disease; Diabetes

Treatments: Drug: ezetimibe

Study type: Interventional

Funder types: Other

Identifiers

NCT01008345

pharmaline1

Details and patient eligibility

About

Randomized study. Patients with coronary artery disease equivalent will be randomized to receive atorvastatin 40 mg/day + placebo vs. atorvastatin 40 mg/day + ezetimibe 40 mg/day. Oxidized LDL cholesterol will be measured at baseline and after 8 weeks of treatment. Hypothesis is that ezetimibe will lower oxidized LDL

Enrollment: 100 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CAD or CAD equivalent

Exclusion criteria

• Prior CABG or PCI within 3 months Prior use of ezetimibe within 3 months Receiving atorvastatin 40 mg/day or 80 mg/day or any dose of rosuvastatin CHF NYHA stage >2 Creatinin clearance < 30 ml/min

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

ezetimibe

Experimental group

Description:

will receive the active treatment with ezetimibe and statin

Treatment:

Drug: ezetimibe

placebo

Placebo Comparator group

Treatment:

Drug: ezetimibe