UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010548 |
|---|---|
| Receipt number | R000012028 |
| Scientific Title | Efficacy of Poststroke Intensive Rosuvastatin Treatment for Aortogenic Embolic Stroke (EPISTEME trial) |
| Date of disclosure of the study information | 2013/04/19 |
| Last modified on | 2016/11/03 10:45:50 |
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Basic information
Public title
Efficacy of Poststroke Intensive Rosuvastatin Treatment for Aortogenic Embolic Stroke (EPISTEME trial)
Acronym
Efficacy of Rosuvastatin therapy for aortogenic embolic stroke
Scientific Title
Efficacy of Poststroke Intensive Rosuvastatin Treatment for Aortogenic Embolic Stroke (EPISTEME trial)
Scientific Title:Acronym
Efficacy of Rosuvastatin therapy for aortogenic embolic stroke
Region
| Japan |
Condition
Condition
Brain infarction or transient ischemic attack with atheromatous plaques in the aortic arch
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We explore the efficacy of Rosuvastation for atheromatous plaque regression in the aortic arch and prevention of ischemic stroke and vascular diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Morphological alteration of atheromatous plaques in the aortic arch
Key secondary outcomes
1) Alteration of atheromatous plaques in the aortic arch
2) Changes in lipid profile
3) Changes in inflammatory markers and white blood cell count
4) Recurrence of ischemic stroke
5) Prevalence of hemorrhagic stroke including intracranial brain hemorrhage and subarachnoid hemorrhage
6) Prevalence of coronary artery disease
7) Other vascular diseases
8) Death
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Treatment with rosuvastatin 5mg daily
Interventions/Control_2
Treatment without rosuvastatin
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
1) Patients with brain infarction or transient ischemic attack within 7 days after onset, having atheromatous aortic plaques greater than 4mm in size
2) Patients with hypercholesterolemia (Serum LDL-C levels greater than 140mg/dL)
Key exclusion criteria
1) Patients during pregnancy or lactation
2) Allergy against statin
3) Patients with coronary artery disease and requiring statin therapy
4) Patients with severe renal dysfunction or liver dysfunction
5) Patients undergoing cyclosporin therapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuji Ueno |
Organization
Juntendo University Urayasu Hospital
Division name
Neurology
Zip code
Address
Tomioka 2-1-1, Urayasu, Chiba, 279-0081, Japan
TEL
0473533111
yuji-u@juntendo.ac.jo
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuji Ueno |
Organization
Juntendo University Urayasu Hospital
Division name
Neurology
Zip code
Address
2-1-1, Tomioka, Urayasu, Chiba, Japan
TEL
0473533111
Homepage URL
yuji-u@juntendo.ac.jo
Sponsor or person
Institute
Department of Neurology, Juntendo Universiy School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
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
順天堂大学医学部附属浦安病院、順天堂医院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 19 | 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
| 2012 | Year | 05 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 18 | 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
| 2013 | Year | 04 | Month | 19 | Day |
Last modified on
| 2016 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012028
