UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006296
Receipt number 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 10:13:22

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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 or person

Institute

Department of Neurology, St. Marianna University School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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