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

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ClinicalTrials.gov Identifier: NCT01104467
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : October 16, 2015
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Drug: Desmoteplase Other: Placebo Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomised, Double-blind, Placebo-controlled, Dose-escalation Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke
Study Start Date : August 2010
Primary Completion Date : August 2013

Arm Intervention/treatment
Experimental: Desmoteplase 70 µg/kg Drug: Desmoteplase
1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)
Experimental: Desmoteplase 90 µg/kg Drug: Desmoteplase
1 bolus injection of desmoteplase 90 µg/kg (IV)
Placebo Comparator: Placebo Other: Placebo
1 bolus injection of placebo IV

Primary Outcome Measures :
  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 [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. To evaluate recanalisation at 18±6 hr after administration of IMP [ Time Frame: 18±6 hr after administration of IMP ]
  4. To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size [ Time Frame: 18±6 hr after administration ]
  5. To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase [ Time Frame: 0.5 - 9 hr ]
  6. To evaluate the immunogenicity of desmoteplase [ Time Frame: Day 7, Day 30, Day 90 ]
  7. To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives [ Time Frame: Day 90 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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 exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01104467

Akita, Japan, 010-0874
Fukuoka, Japan, 810-8563
Hiroshima, Japan, 734-8551
Isesaki, Japan, 374-0006
Kagoshima, Japan, 892-0853
Kawasaki, Japan, 216-8511
Kobe, Japan, 650-0046
Kumamoto, Japan, 861-4193
Nagoy, Japan, 466-8650
Nishinomiya, Japan, 662-0934
Okayama, Japan, 701-0192
Sapporo,Hokkaido, Japan, 006-8555
Sapporo, Japan, 060-8570
Sendai, Japan, 982-0012
Shibata, Japan, 989-1253
Suita, Japan, 565-8565
Tokushima, Japan, 770-8503
Tokyo, Japan, 145-0065
Toyota, Japan, 471-8513
Sponsors and Collaborators
Lundbeck Japan K. K.
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Lundbeck Japan K. K.
ClinicalTrials.gov Identifier: NCT01104467     History of Changes
Other Study ID Numbers: 11764A
First Posted: April 15, 2010    Key Record Dates
Last Update Posted: October 16, 2015
Last Verified: October 2015

Keywords provided by Lundbeck Japan K. K.:
Acute Ischemic Stroke

Additional relevant MeSH terms:
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Salivary plasminogen activator alpha 1, Desmodus rotundus
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action