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

Primary Purpose

Acute Ischemic Stroke

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
Desmoteplase
Desmoteplase
Placebo
Sponsored by
Lundbeck Japan K. K.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring Acute Ischemic Stroke, Desmoteplase, Japan, Safety, Stroke, Tolerability

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • JP006
  • JP021
  • JP018
  • JP007
  • JP024
  • JP011
  • JP015
  • JP022
  • JP012
  • JP026
  • JPO17
  • JP002
  • JP001
  • JP004
  • JP005
  • JP014
  • JP020
  • JP009
  • JP013

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Desmoteplase 70 µg/kg

Desmoteplase 90 µg/kg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 8, 2010
Last Updated
August 30, 2021
Sponsor
Lundbeck Japan K. K.
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1. Study Identification

Unique Protocol Identification Number
NCT01104467
Brief Title
Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
Acronym
DIAS-J
Official Title
Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lundbeck Japan K. K.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
Keywords
Acute Ischemic Stroke, Desmoteplase, Japan, Safety, Stroke, Tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Desmoteplase 70 µg/kg
Arm Type
Experimental
Arm Title
Desmoteplase 90 µg/kg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Desmoteplase
Intervention Description
1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)
Intervention Type
Drug
Intervention Name(s)
Desmoteplase
Intervention Description
1 bolus injection of desmoteplase 90 µg/kg (IV)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
1 bolus injection of placebo IV
Primary Outcome Measure Information:
Title
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
Time Frame
90 days
Secondary Outcome Measure Information:
Title
To evaluate the clinical improvement at Day 90 after administration of Investigational Medicinal Product (IMP) as measured by modified Rankin Scale (mRS)
Time Frame
90 days
Title
To evaluate the clinical improvement at Day 7 and 30 after administration of IMP as measured by modified Rankin Scale (mRS)
Time Frame
Day 7 and Day 30
Title
To evaluate recanalisation at 18±6 hr after administration of IMP
Time Frame
18±6 hr after administration of IMP
Title
To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size
Time Frame
18±6 hr after administration
Title
To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase
Time Frame
0.5 - 9 hr
Title
To evaluate the immunogenicity of desmoteplase
Time Frame
Day 7, Day 30, Day 90
Title
To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives
Time Frame
Day 90

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Email contact via H. Lundbeck A/S
Organizational Affiliation
LundbeckClinicalTrials@lundbeck.com
Official's Role
Study Director
Facility Information:
Facility Name
JP006
City
Akita
ZIP/Postal Code
010-0874
Country
Japan
Facility Name
JP021
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
Facility Name
JP018
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
JP007
City
Isesaki
ZIP/Postal Code
374-0006
Country
Japan
Facility Name
JP024
City
Kagoshima
ZIP/Postal Code
892-0853
Country
Japan
Facility Name
JP011
City
Kawasaki
ZIP/Postal Code
216-8511
Country
Japan
Facility Name
JP015
City
Kobe
ZIP/Postal Code
650-0046
Country
Japan
Facility Name
JP022
City
Kumamoto
ZIP/Postal Code
861-4193
Country
Japan
Facility Name
JP012
City
Nagoya
ZIP/Postal Code
466-8650
Country
Japan
Facility Name
JP026
City
Nishinomiya
ZIP/Postal Code
662-0934
Country
Japan
Facility Name
JPO17
City
Okayama
ZIP/Postal Code
701-0192
Country
Japan
Facility Name
JP002
City
Sapporo,Hokkaido
ZIP/Postal Code
006-8555
Country
Japan
Facility Name
JP001
City
Sapporo
ZIP/Postal Code
060-8570
Country
Japan
Facility Name
JP004
City
Sendai
ZIP/Postal Code
982-0012
Country
Japan
Facility Name
JP005
City
Shibata
ZIP/Postal Code
989-1253
Country
Japan
Facility Name
JP014
City
Suita
ZIP/Postal Code
565-8565
Country
Japan
Facility Name
JP020
City
Tokushima
ZIP/Postal Code
770-8503
Country
Japan
Facility Name
JP009
City
Tokyo
ZIP/Postal Code
145-0065
Country
Japan
Facility Name
JP013
City
Toyota
ZIP/Postal Code
471-8513
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26251244
Citation
Mori E, Minematsu K, Nakagawara J, Hasegawa Y, Nagahiro S, Okada Y, Truelsen T, Lindsten A, Ogawa A, Yamaguchi T; DIAS-J Investigators. Safety and Tolerability of Desmoteplase Within 3 to 9 Hours After Symptoms Onset in Japanese Patients With Ischemic Stroke. Stroke. 2015 Sep;46(9):2549-54. doi: 10.1161/STROKEAHA.115.009917. Epub 2015 Aug 6.
Results Reference
derived

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Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke

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