UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004200 |
|---|---|
| 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 |
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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
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
tomoitoh@iwate-med.ac.jp
Sponsor or person
Institute
Division of cardiology, Department of Internal Medicine, Memorial Heart Center, Iwate Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002440
