A study to evaluate the effect of ezetimibe and rosuvastatin on intravascular ultrasound-derived coronary atheroma and lipid lowering effect.

UMIN ID: UMIN000010323

Registered date:27/03/2013

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: dyslipidemia
• Date of first enrollment: 2008/10/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

statin only arm
statin with ezetimibe arm

Outcome(s)

• Primary Outcome: The change in coronary atheroma by serial volumetoric intravascular-ultrasound analysis
• Secondary Outcome: body mass index, serum LDL-C, HDL-C, TG, non-HDL, small dense LDL, hs-CRP, HOMA-IR, oxidized LDL and hs-CRP

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: 1, privious allergy for ezetimibe or any of statins 2, contraindication for rosuvastatin and already recieved rosuvastatin 3, secondary dyslipidemia 4, history of acute coronary syndrome within 3months before study entry 5, congestive heart failure (NYHA 3 or 4) 6, low left ventricular contractility 7, inducation for coronary artery bypass graft 8, poor control HTN patient (systolic BP over 220mmHg, diastolic BP over 110mmHg) 9, poor control diabetic patient (HbA1c over 9.5%) 10, hemodialysis patient 11, severe renal dysfunction (30 over CCr or serum Cre over 2.0) 12, serum CK over 300 13, severe liver dysfunction

Related Information

• Primary Sponsor: Department of Cardiology and Nephrology, Mie University Graduate School of Medicine
• Secondary Sponsor: Clinical Research Support Center, Mie University Hospital
• Source(s) of Monetary Support: Department of Cardiology and Nephrology, Mie University Graduate School of Medicine