Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke (DIAS-J)

Inclusion Criteria:

• Clinical diagnosis of acute ischemic stroke
• 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:

• Pre-stroke mRS score of >1
• 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

Other inclusion and exclusion criteria may apply.