UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003893 |
|---|---|
| Receipt number | R000004686 |
| Scientific Title | Aggressive choresterol lowing therapy by strong statin from acute phase of acute myocardial infarction. |
| Date of disclosure of the study information | 2010/07/12 |
| Last modified on | 2013/06/24 20:53:53 |
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Basic information
Public title
Aggressive choresterol lowing therapy by strong statin from acute phase of acute myocardial infarction.
Acronym
ROYAL-AMI
Scientific Title
Aggressive choresterol lowing therapy by strong statin from acute phase of acute myocardial infarction.
Scientific Title:Acronym
ROYAL-AMI
Region
| Japan |
Condition
Condition
ST-segment elevation myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the intensive choresterol lowing therapy by strong statin(rosuvastatin, atorvastatin) aiming cardiac or vascular protection and improvement of cardic function by evaluation of damaged myocardial marker, ultrasound cardiography, myocardial scintigram in patients with STEMI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
MSI(myocardial salvage index) assessed by SPECT
Key secondary outcomes
Various parameters of echocardiography, BNP levels and CoQ10 levels
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
rosuvastatin
Interventions/Control_2
atorvastatin
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients admitted with AMI and treated with PCI, accompanied with LDL-C level >70mg/dl.
Key exclusion criteria
1. Familial hyper cholesteremia
2. Cyclospolin taking
3. Liver dysfunction
4. Renal failure
5. Pregnancy or possible
6. Hypothyroidism
7. Hereditary muscle disease
8. Drug or alcohol addiction
9. Hemodynamical Unstable condition
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisao Ogawa |
Organization
Kumamoto University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Honjo 1-1-1, Kumamoto
TEL
096-373-5175
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Seigo Sugiyama |
Organization
Kumamoto University School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
Honjo 1-1-1, Kumamoto
TEL
096-373-5175
Homepage URL
ssugiyam@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Cardiovascular Medicine
Kumamoto University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research Fund Donation
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
熊本大学附属病院（熊本）、 福岡徳洲会病院（福岡）、大牟田天領病院（福岡）
熊本赤十字病院（熊本）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 07 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Open public recruiting
Date of protocol fixation
| 2008 | Year | 02 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 09 | 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 | 07 | Month | 08 | Day |
Last modified on
| 2013 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004686
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
