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


Phase 2 Results N/A

Eligibility Criteria

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.