Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with Acute coronary Syndrome (ATRAS study)

UMIN ID: UMIN000004200

Registered date:13/09/2010

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Coronary Artery Disease
• Date of first enrollment: 2008/12/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Atorvastatin (10mg/day). Study preriod is Dec. 2008-Sep. 2010.
Rosvastatin (2.5mg/day) Study preriod is Dec. 2008-Sep. 2010.

Outcome(s)

• Primary Outcome: 1:plaque evaluation using IVUS 2:EPC function, immunological response of monocyto 3:all cause death, all cause cardiovascular event 4:repeat revascularization

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Exclusion Criteria 1) stand by scheduled CABG during study period 2) valvelar heart disease 3) chronic lung disease, cor plumonale 4) poor prognosis disease (malignant tumor etc.) within 5 years 5) bilateral renal artery stenosis, one-side kidney and renal artery stenosis, high potassium (K 5.0mEq/L), renal insufficiency (creatine 3.0mg/dL), liver dysfunction (AST>100 U/L, ALT>100U/L), anemia (Hb <6.0mg/dL) 6) in pregnancy (including suspicious state) , the lactation period 7) drug allergy for HMG-CoA reductase inhibitor 8) contraindication of HMG-CoA reductase inhibitor 9) could not obtained written informed consent 10) unfavorable patient for this study protocol

Related Information

• Primary Sponsor: Division of cardiology, Department of Internal Medicine, Memorial Heart Center, Iwate Medical University
• Source(s) of Monetary Support: Division of cardiology, Department of Internal Medicine, Memorial Heart Center, Iwate Medical University