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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006296
Receipt No. R000007446
Scientific Title Early statin treatment against progressing stroke. A Randomised pilot study
Date of disclosure of the study information 2011/09/20
Last modified on 2012/09/07

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Basic information
Public title Early statin treatment against progressing stroke. A Randomised pilot study
Acronym Early statin treatment against progressing stroke. A Randomised pilot study
Scientific Title Early statin treatment against progressing stroke. A Randomised pilot study
Scientific Title:Acronym Early statin treatment against progressing stroke. A Randomised pilot study
Region
Japan

Condition
Condition acute ischemic stroke
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To identify whether acute statin treatment witin 48 hrs after stroke
onset prevents progression of neurological deficits and to identify the association between protective effect and changes in proinflammatory biomarkers after the treatment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase III

Assessment
Primary outcomes 1. Progression in stroke deficits within 14 days(NIHSS>4)
2. Changes in proinfalmmatory biomarkers; hsCRP, IL-6, IL-10, IL-18, MMP-2, MMP-9, TNF-alpha at Day-1,Day-3, Day-7, Day14.
Key secondary outcomes 1. infarct volume
2. mRS<2 at 90 days

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Early statin group: atorvastatin 10mg/day immediately after the entry (<48hrs after onset). Statin treatment may be initiated via nasal tube in patients with swallowing difficulty.
Interventions/Control_2 Delyed statin group: atorvastatin 10mg/day 14days after the entry
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria Entry criteria
1. ischemic stroke defined by MRI-DWI.
2. <48 hours after onset
3. Patients have dyslipidemia.
Key exclusion criteria Exclusion criteria
1. statin treatment within 3 months
2. chronic devastating illness
3. stroke caused by arterial dissection, or moyamoya disease
4. acute ischemic heart disease, severe inflammatory disease, autoimmune disease, collagen disease or malignancy requiring treatment
5. pregnancy or possibility of pregnancy
6. recurrent cerebral infarction that had developed 6 months after the previous episode
7. disability with modified Rankin scale (mRS) score &#8805;2 before onset
8.steroid or NSAID treatment
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhiro Hasegawa
Organization St. Marianna University School of Medicine
Division name Department of Neurology
Zip code
Address 1-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, JAPAN
TEL 044-977-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuhiro Hasegawa
Organization St. Marianna University School of Medicine
Division name Department of Neurology
Zip code
Address 1-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, JAPAN
TEL 044-977-8111
Homepage URL
Email hasegawa-neuro1@marianna-u.ac.jp

Sponsor
Institute Department of Neurology, St. Marianna University School of Medicine
Institute
Department

Funding Source
Organization Grants-in-Aid for Scientific Research (c) No 21590778
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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 聖マリアンナ医科大学病院(神奈川県)

Other administrative information
Date of disclosure of the study information
2011 Year 09 Month 20 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
2008 Year 02 Month 13 Day
Date of IRB
Anticipated trial start date
2008 Year 03 Month 01 Day
Last follow-up date
2012 Year 03 Month 01 Day
Date of closure to data entry
2012 Year 03 Month 01 Day
Date trial data considered complete
2012 Year 06 Month 01 Day
Date analysis concluded
2012 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 09 Month 06 Day
Last modified on
2012 Year 09 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007446

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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