Unique ID issued by UMIN | UMIN000006296 |
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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 |
Early statin treatment against progressing stroke. A Randomised pilot study
Early statin treatment against progressing stroke. A Randomised pilot study
Early statin treatment against progressing stroke. A Randomised pilot study
Early statin treatment against progressing stroke. A Randomised pilot study
Japan |
acute ischemic stroke
Neurology |
Others
NO
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
Efficacy
Exploratory
Explanatory
Phase III
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.
1. infarct volume
2. mRS<2 at 90 days
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
No need to know
2
Treatment
Medicine |
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.
Delyed statin group: atorvastatin 10mg/day 14days after the entry
18 | years-old | <= |
90 | years-old | > |
Male and Female
Entry criteria
1. ischemic stroke defined by MRI-DWI.
2. <48 hours after onset
3. Patients have dyslipidemia.
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 ≥2 before onset
8.steroid or NSAID treatment
80
1st name | |
Middle name | |
Last name | Yasuhiro Hasegawa |
St. Marianna University School of Medicine
Department of Neurology
1-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, JAPAN
044-977-8111
1st name | |
Middle name | |
Last name | Yasuhiro Hasegawa |
St. Marianna University School of Medicine
Department of Neurology
1-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, JAPAN
044-977-8111
hasegawa-neuro1@marianna-u.ac.jp
Department of Neurology, St. Marianna University School of Medicine
Grants-in-Aid for Scientific Research (c) No 21590778
Japan
NO
聖マリアンナ医科大学病院(神奈川県)
2011 | Year | 09 | Month | 20 | Day |
Unpublished
Completed
2008 | Year | 02 | Month | 13 | Day |
2008 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 03 | Month | 01 | Day |
2012 | Year | 06 | Month | 01 | Day |
2012 | Year | 08 | Month | 31 | Day |
2011 | Year | 09 | Month | 06 | Day |
2012 | Year | 09 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007446
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