Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke

Phase 2

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Other: Placebo; Drug: Desmoteplase

• Registration Number: NCT01104467
• Lead Sponsor: Lundbeck Japan K. K.

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

Study Timeline

• Study First Submitted: 2010-04-08
• Study First Submitted QC: 2010-04-13
• Study First Posted: 2010-04-15
• Study Start: 2010-08
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Desmoteplase 70 µg/kg	Desmoteplase	-
Desmoteplase 90 µg/kg	Desmoteplase	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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 change in infarct size at 18±6 hr relative to pre-treatment infarct size	18±6 hr after administration
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

Trial Locations

Locations (19)

JP024; 🇯🇵 Kagoshima, Japan

JP011; 🇯🇵 Kawasaki, Japan

JP004; 🇯🇵 Sendai, Japan

JP014; 🇯🇵 Suita, Japan

JP009; 🇯🇵 Tokyo, Japan

JP012; 🇯🇵 Nagoya, Japan

JP001; 🇯🇵 Sapporo, Japan

JP005; 🇯🇵 Shibata, Japan

JP013; 🇯🇵 Toyota, Japan

JP006; 🇯🇵 Akita, Japan

JP021; 🇯🇵 Fukuoka, Japan

JP022; 🇯🇵 Kumamoto, Japan

JP026; 🇯🇵 Nishinomiya, Japan

JP018; 🇯🇵 Hiroshima, Japan

JP002; 🇯🇵 Sapporo,Hokkaido, Japan

JP007; 🇯🇵 Isesaki, Japan

JP015; 🇯🇵 Kobe, Japan

JP020; 🇯🇵 Tokushima, Japan

JPO17; 🇯🇵 Okayama, Japan