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

Phase 4

Completed

• Conditions: Coronary Artery Disease; Diabetes
• Interventions: Drug: ezetimibe

• Registration Number: NCT01008345
• Lead Sponsor: Hotel Dieu de France Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2009-11
• Study First Submitted: 2009-11-04
• Study First Submitted QC: 2009-11-04
• Study First Posted: 2009-11-05
• Last Update Submitted: 2009-11-05
• Last Update Posted: 2009-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ezetimibe	ezetimibe	will receive the active treatment with ezetimibe and statin
placebo	ezetimibe	-

Primary Outcome Measures

Name	Time	Method
level of oxidized LDL cholesterol at end of study	8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
small dense LDL level	8 weeks of treatment

Trial Locations

Locations (1)

Hotel Dieu de France Hospital; 🇱🇧 Achrafieh, Beirut, Lebanon