Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke

Acute Ischemic Stroke Clinical Trial

— DIAS-J  

Official title:

Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01104467
• Other study ID #: 11764A
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Est. completion date: August 2013

Study information

• Verified date: August 2021
• Source: Lundbeck Japan K. K.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Cerebral Infarction
• Ischemia
• Stroke

Intervention

Drug:
• Desmoteplase
1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)
• Desmoteplase
1 bolus injection of desmoteplase 90 µg/kg (IV)

Other:
• Placebo
1 bolus injection of placebo IV

Locations

Country	Name	City	State
Japan	JP006	Akita
Japan	JP021	Fukuoka
Japan	JP018	Hiroshima
Japan	JP007	Isesaki
Japan	JP024	Kagoshima
Japan	JP011	Kawasaki
Japan	JP015	Kobe
Japan	JP022	Kumamoto
Japan	JP012	Nagoya
Japan	JP026	Nishinomiya
Japan	JPO17	Okayama
Japan	JP001	Sapporo
Japan	JP002	Sapporo,Hokkaido
Japan	JP004	Sendai
Japan	JP005	Shibata
Japan	JP014	Suita
Japan	JP020	Tokushima
Japan	JP009	Tokyo
Japan	JP013	Toyota

Sponsors (1)

Lead Sponsor	Collaborator
Lundbeck Japan K. K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	To evaluate the clinical improvement at Day 90 after administration of Investigational Medicinal Product (IMP) as measured by modified Rankin Scale (mRS)		90 days
Secondary	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
Secondary	To evaluate recanalisation at 18±6 hr after administration of IMP		18±6 hr after administration of IMP
Secondary	To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size		18±6 hr after administration
Secondary	To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase		0.5 - 9 hr
Secondary	To evaluate the immunogenicity of desmoteplase		Day 7, Day 30, Day 90
Secondary	To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives		Day 90

External Links

•   Publication: "Safety and Tolerability of Desmoteplase Within 3 to 9 Hours After Symptoms Onset in Japanese Patients With Ischemic Stroke"