UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004200
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with Acute coronary Syndrome (ATRAS study)
Acronym ATRAS study
Scientific Title Pharmacological intervention of Atorvastatin vs. Rosvastatin in patients with Acute coronary Syndrome (ATRAS study)
Scientific Title:Acronym 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
1st name
Middle name
Last name Tomonori Itoh
Organization Iwate Medical University
Division name Division of Cardiology,Department of Internal Medicine, Memorial Heart Center
Zip code
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
1st name
Middle name
Last name Tomonori Itoh
Organization Iwate Medical University
Division name Division of cardiology, Department of Internal Medicine, Memorial Heart Center
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2008 Year 09 Month 04 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.