Unique ID issued by UMIN | C000000296 |
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Receipt number | R000000376 |
Scientific Title | Comparison of the effects between ozagrel Na combined with cilostazol and ozagrel Na alone for acute phase ischemic stroke in the territory of perforating arteries of the MCA; a randomized open trial. |
Date of disclosure of the study information | 2005/12/16 |
Last modified on | 2006/01/13 18:52:59 |
Comparison of the effects between ozagrel Na combined with cilostazol and ozagrel Na alone for acute phase ischemic stroke in the territory of perforating arteries of the MCA; a randomized open trial.
Efficacy of cilostazol in the treatment of acute phase ischemic stroke in the territory of perforating arteries of the MCA.
Comparison of the effects between ozagrel Na combined with cilostazol and ozagrel Na alone for acute phase ischemic stroke in the territory of perforating arteries of the MCA; a randomized open trial.
Efficacy of cilostazol in the treatment of acute phase ischemic stroke in the territory of perforating arteries of the MCA.
Japan |
Ischemic stroke
Neurology | Neurosurgery |
Others
NO
To assess whether administration of cilostazol provides an clinical benefit of patients with acute phase ischemic stroke.
Efficacy
Exploratory
Explanatory
Not applicable
The frequency of patients with 'minimal or no neurological disability (defined as modified Rankin scale 0-2)' at 1 month into the treatment.
(1)The frequency of neurological deterioration within 14 days into the treatment.
(2)NIHSS at 1 month into the treatment
(3)BI at 1 month into the treatment
(4)Vascular or other adverse events
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Numbered container method
2
Treatment
Medicine |
Patients will be randomly selected to receive combined therapy with ozagrel Na and cilostazol for 14 days. Cilostazol will be administered orally at a daily dose of 200mg.
Patients will also be randomly selected to receive treatment with ozagrel Na alone for 14 days.
20 | years-old | <= |
Not applicable |
Male and Female
(1)Initial attack of stroke
(2)Beginning of treatment within 48 hours after the onset of symptoms
(3)Infarction in the territory of the perforating arteries of the MCA, which should be defined by MR DW image.
(4)Informed consent
(1)Occlusive lesion of the internal carotid artery or the middle cerebral artery
(2)Hemorrhagic disorders
(3)Congestive heart failure
(4)Embolic stroke
(5)Severe liver and renal dysfunction
(6)Malignant disorders
(7)Taking cilostazol, ticlipidine
, aspirin or warfarin
(8)The patient participating in
other clinical trials
100
1st name | |
Middle name | |
Last name | Yasushi Matsumoto |
Kohnan Hospital
Department of Neuroendovascular
4-20-1 Nagamachi-minami Taihaku-ku Sendai Miyagi Japan
022-248-3585
1st name | |
Middle name | |
Last name | Ryushi Kondoh |
Iwate medical university
Department of Neurology
19-1 Uchimaru Morioka Iwate Japan
019-651-5111
rkondoh@iwate-med.ac.jp
Kohnan Hospital Department of Neuroendovascular Therapy
None
Self funding
None
NO
2005 | Year | 12 | Month | 16 | Day |
Unpublished
2005 | Year | 12 | Month | 05 | Day |
2006 | Year | 01 | Month | 01 | Day |
2008 | Year | 03 | Month | 01 | Day |
2005 | Year | 12 | Month | 14 | Day |
2006 | Year | 01 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000376
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