UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with Acute coronary Syndrome (ATRAS study)
Title of the study (Brief title)	ATRAS study
Region	Japan

Condition
Condition	Coronary Artery Disease
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To prospective evaluate of atorvastatin and rosvastatin efficacy in patients with coronary artery disease after coronary intervention.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Phase IV

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

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Atorvastatin (10mg/day). Study preriod is Dec. 2008-Sep. 2010.
Interventions/Control_2	Rosvastatin (2.5mg/day) Study preriod is Dec. 2008-Sep. 2010.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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
Key exclusion 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
Target sample size	100

Research contact person
Name of lead principal investigator	Tomonori Itoh
Organization	Iwate Medical University
Division name	Division of Cardiology,Department of Internal Medicine, Memorial Heart Center
Address	19-1, Uchimaru, Morioka city, Iwate 020-8505, Japan
TEL	019-651-5111
Email	tomoitoh@iwate-med.ac.jp

Public contact
Name of contact person	Tomonori Itoh
Organization	Iwate Medical University
Division name	Division of cardiology, Department of Internal Medicine, Memorial Heart Center
Address	19-1, Uchimaru, Morioka city, Iwate 020-8505, Japan
TEL	019-651-5111
Homepage URL
Email	tomoitoh@iwate-med.ac.jp

Sponsor
Institute	Division of cardiology, Department of Internal Medicine, Memorial Heart Center, Iwate Medical University
Institute
Department

Funding Source
Organization	Division of cardiology, Department of Internal Medicine, Memorial Heart Center, Iwate Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	岩手医科大学循環器医療センター（岩手県）

Other administrative information
Date of disclosure of the study information	2010 Year 09 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 09 Month 04 Day
Anticipated trial start date	2008 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2010 Year 09 Month 13 Day
Last modified on	2016 Year 10 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002440