Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lundbeck Japan K. K.
• Treatments: Salivary plasminogen activator alpha 1, Desmodus rotundus

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.