Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
NCT ID: NCT01104467
Last Updated: 2021-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
48 participants
INTERVENTIONAL
2010-08-31
2013-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Desmoteplase 70 µg/kg
Desmoteplase
1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)
Desmoteplase 90 µg/kg
Desmoteplase
1 bolus injection of desmoteplase 90 µg/kg (IV)
Placebo
Placebo
1 bolus injection of placebo IV
Interventions
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Desmoteplase
1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)
Desmoteplase
1 bolus injection of desmoteplase 90 µg/kg (IV)
Placebo
1 bolus injection of placebo IV
Eligibility Criteria
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Inclusion Criteria
* Provided Informed Consent
* Male or female
* Aged between 20 and 85 years inclusive
* Treatment within 3-9 hr after onset of stroke symptoms.
* NIHSS score of 4-24 inclusive with clinical signs of hemispheric infarction
* Must receive IMP within 60 minutes after brain imaging
* Cerebral artery occlusion or high-grade stenosis in MCA
Exclusion Criteria
* Previously exposed to desmoteplase
* Scores \>2 on NIHSS question 1a indicating coma
* History or clinical presentation of ICH, subarachnoid haemorrhage (SAH), arterio-venous malformation (AVM), moyamoya disease, cerebral neoplasm or aneurysm
* Current use of oral anticoagulants and a prolonged prothrombin time (INR \>1.6)
* Treated with heparin in the previous 48 hours and has a prolonged partial thromboplastin time
* Baseline platelet count \<100,000/mm3
* Baseline haematocrit of \<0.25
* Baseline blood glucose \<50 mg/dl or \>200 mg/dl
* Uncontrolled hypertension defined by a blood pressure, systolic \>185 mmHg or diastolic \>110 mmHg on at least 2 separate occasions at least 10 minutes apart
* Patient has hereditary or acquired hemorrhagic diathesis
* Gastrointestinal or urinary bleeding within the past 21 days
* Arterial puncture in a non-compressible site within the previous 7 days
* Another stroke or a serious head injury in the past 6 weeks
* Major surgery or serious injury, including other sites than the head, within the preceding 14 days
* Seizure at the onset of stroke
* Acute myocardial infarction (AMI) within the previous 3 weeks
* Thrombolytic within the previous 72 hr
* Pregnant
20 Years
85 Years
ALL
No
Sponsors
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Lundbeck Japan K. K.
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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JP006
Akita, , Japan
JP021
Fukuoka, , Japan
JP018
Hiroshima, , Japan
JP007
Isesaki, , Japan
JP024
Kagoshima, , Japan
JP011
Kawasaki, , Japan
JP015
Kobe, , Japan
JP022
Kumamoto, , Japan
JP012
Nagoya, , Japan
JP026
Nishinomiya, , Japan
JPO17
Okayama, , Japan
JP001
Sapporo, , Japan
JP002
Sapporo,Hokkaido, , Japan
JP004
Sendai, , Japan
JP005
Shibata, , Japan
JP014
Suita, , Japan
JP020
Tokushima, , Japan
JP009
Tokyo, , Japan
JP013
Toyota, , Japan
Countries
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References
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Mori E, Minematsu K, Nakagawara J, Hasegawa Y, Nagahiro S, Okada Y, Truelsen T, Lindsten A, Ogawa A, Yamaguchi T; DIAS-J Investigators. Safety and Tolerability of Desmoteplase Within 3 to 9 Hours After Symptoms Onset in Japanese Patients With Ischemic Stroke. Stroke. 2015 Sep;46(9):2549-54. doi: 10.1161/STROKEAHA.115.009917. Epub 2015 Aug 6.
Related Links
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Publication: "Safety and Tolerability of Desmoteplase Within 3 to 9 Hours After Symptoms Onset in Japanese Patients With Ischemic Stroke"
Other Identifiers
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11764A
Identifier Type: -
Identifier Source: org_study_id
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