Unique ID issued by UMIN | UMIN000004200 |
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Receipt number | R000002440 |
Scientific Title | Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with Acute coronary Syndrome (ATRAS study) |
Date of disclosure of the study information | 2010/09/13 |
Last modified on | 2016/10/24 18:49:57 |
Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with Acute coronary Syndrome (ATRAS study)
ATRAS study
Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with Acute coronary Syndrome (ATRAS study)
ATRAS study
Japan |
Coronary Artery Disease
Cardiology |
Others
YES
To prospective evaluate of atorvastatin and rosvastatin efficacy in patients with coronary artery disease after coronary intervention.
Efficacy
Phase IV
1:plaque evaluation using IVUS
2:EPC function, immunological response of monocyto
3:all cause death, all cause cardiovascular event
4:repeat revascularization
Interventional
Parallel
Randomized
Individual
Single blind -investigator(s) and assessor(s) are blinded
Active
2
Treatment
Medicine |
Atorvastatin (10mg/day).
Study preriod is Dec. 2008-Sep. 2010.
Rosvastatin (2.5mg/day)
Study preriod is Dec. 2008-Sep. 2010.
20 | years-old | <= |
Not applicable |
Male and Female
Inclusion Criteria
1) Coroanry artery disease with hyperlipidemia,
2) Acceptable for prescription of Atorvastatin and rosvastatin
3) ACC/AHA guideline diagnositic criteria (J Am Coll Cardiol. 2002;40:1366-74)
4) Patients after coronary intervention
5) Acceptable follow up in our center
6) Age: over 20 years old
7) Sex: undetermined
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
100
1st name | |
Middle name | |
Last name | Tomonori Itoh |
Iwate Medical University
Division of Cardiology,Department of Internal Medicine, Memorial Heart Center
19-1, Uchimaru, Morioka city, Iwate 020-8505, Japan
019-651-5111
tomoitoh@iwate-med.ac.jp
1st name | |
Middle name | |
Last name | Tomonori Itoh |
Iwate Medical University
Division of cardiology, Department of Internal Medicine, Memorial Heart Center
19-1, Uchimaru, Morioka city, Iwate 020-8505, Japan
019-651-5111
tomoitoh@iwate-med.ac.jp
Division of cardiology, Department of Internal Medicine, Memorial Heart Center, Iwate Medical University
Division of cardiology, Department of Internal Medicine, Memorial Heart Center, Iwate Medical University
Self funding
NO
岩手医科大学循環器医療センター(岩手県)
2010 | Year | 09 | Month | 13 | Day |
Unpublished
Completed
2008 | Year | 09 | Month | 04 | Day |
2008 | Year | 12 | Month | 01 | Day |
2010 | Year | 09 | Month | 13 | Day |
2016 | Year | 10 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002440
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