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 UMIN000010548
Receipt No. 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

* 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 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
Email 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
Email yuji-u@juntendo.ac.jo

Sponsor
Institute Department of Neurology, Juntendo Universiy School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012028

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.