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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003893
Receipt No. 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

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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
Email

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
Email ssugiyam@kumamoto-u.ac.jp

Sponsor
Institute Department of Cardiovascular Medicine
Kumamoto University School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004686

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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