Acute Ischemic Stroke
Conditions
Keywords
Acute Ischemic Stroke, Desmoteplase, Japan, Safety, Stroke, Tolerability
Brief summary
The purpose of the study is to evaluate whether desmoteplase is safe and tolerated when given to Japanese patients with acute ischemic stroke
Detailed description
The study is a safety and tolerability study of desmoteplase in Japanese patients with acute ischemic stroke. The study will test two doses
Interventions
DRUGDesmoteplase
1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)
OTHERPlacebo
1 bolus injection of placebo IV
Sponsors
Lundbeck Japan K. K.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the safety and tolerability of desmoteplase doses of 70 µg/kg and 90 µg/kg in Japanese patients with acute ischemic stroke as measured by the presence of symptomatic intracranial haemorrhage (sICH) within 72 hours after IMP | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives | Day 90 |
| To evaluate the clinical improvement at Day 90 after administration of Investigational Medicinal Product (IMP) as measured by modified Rankin Scale (mRS) | 90 days |
| To evaluate the clinical improvement at Day 7 and 30 after administration of IMP as measured by modified Rankin Scale (mRS) | Day 7 and Day 30 |
| To evaluate the immunogenicity of desmoteplase | Day 7, Day 30, Day 90 |
| To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size | 18±6 hr after administration |
| To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase | 0.5 - 9 hr |
| To evaluate recanalisation at 18±6 hr after administration of IMP | 18±6 hr after administration of IMP |
Countries
Japan
Outcome results
None listed