Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
DIAS-J
Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
1 other identifier
interventional
48
1 country
19
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2010
Typical duration for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedAugust 31, 2021
August 1, 2021
3 years
April 8, 2010
August 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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 recanalisation at 18±6 hr after administration of IMP
18±6 hr after administration of IMP
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
- +2 more secondary outcomes
Study Arms (3)
Desmoteplase 70 µg/kg
EXPERIMENTALDesmoteplase 90 µg/kg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
JP006
Akita, 010-0874, Japan
JP021
Fukuoka, 810-8563, Japan
JP018
Hiroshima, 734-8551, Japan
JP007
Isesaki, 374-0006, Japan
JP024
Kagoshima, 892-0853, Japan
JP011
Kawasaki, 216-8511, Japan
JP015
Kobe, 650-0046, Japan
JP022
Kumamoto, 861-4193, Japan
JP012
Nagoya, 466-8650, Japan
JP026
Nishinomiya, 662-0934, Japan
JPO17
Okayama, 701-0192, Japan
JP001
Sapporo, 060-8570, Japan
JP002
Sapporo,Hokkaido, 006-8555, Japan
JP004
Sendai, 982-0012, Japan
JP005
Shibata, 989-1253, Japan
JP014
Suita, 565-8565, Japan
JP020
Tokushima, 770-8503, Japan
JP009
Tokyo, 145-0065, Japan
JP013
Toyota, 471-8513, Japan
Related Publications (1)
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.
PMID: 26251244DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Email contact via H. Lundbeck A/S
LundbeckClinicalTrials@lundbeck.com
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2010
First Posted
April 15, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
August 31, 2021
Record last verified: 2021-08