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

Lundbeck

Status and phase: Completed; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Other: Placebo; Drug: Desmoteplase

Study type: Interventional

Funder types: Industry

Identifiers

NCT01104467

11764A

Details and patient eligibility

About

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

Full description

The study is a safety and tolerability study of desmoteplase in Japanese patients with acute ischemic stroke. The study will test two doses

Enrollment: 48 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 3 patient groups, including a placebo group

Desmoteplase 70 µg/kg

Experimental group

Treatment:

Drug: Desmoteplase

Drug: Desmoteplase

Desmoteplase 90 µg/kg

Experimental group

Treatment:

Drug: Desmoteplase

Drug: Desmoteplase

Placebo

Placebo Comparator group

Treatment:

Other: Placebo