UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Poststroke Intensive Rosuvastatin Treatment for Aortogenic Embolic Stroke (EPISTEME trial)
Title of the study (Brief title)	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	Yuji Ueno
Organization	Juntendo University Urayasu Hospital
Division name	Neurology
Address	Tomioka 2-1-1, Urayasu, Chiba, 279-0081, Japan
TEL	0473533111
Email	yuji-u@juntendo.ac.jo

Public contact
Name of contact person	Yuji Ueno
Organization	Juntendo University Urayasu Hospital
Division name	Neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000012028