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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lundbeck Japan K. K.
ClinicalTrials.gov Identifier:
NCT01104467
First received: April 8, 2010
Last updated: September 12, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention Phase
Acute Ischemic Stroke
Drug: Desmoteplase
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Further study details as provided by Lundbeck Japan K. K.:

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 [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

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) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To evaluate recanalisation at 18±6 hr after administration of IMP [ Time Frame: 18±6 hr after administration of IMP ] [ Designated as safety issue: No ]
  • To evaluate change in infarct size at 18±6 hr relative to pre-treatment infarct size [ Time Frame: 18±6 hr after administration ] [ Designated as safety issue: No ]
  • To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase [ Time Frame: 0.5 - 9 hr ] [ Designated as safety issue: No ]
  • To evaluate the immunogenicity of desmoteplase [ Time Frame: Day 7, Day 30, Day 90 ] [ Designated as safety issue: No ]
  • To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: August 2010
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01104467

Locations
Japan
JP006
Akita, Japan, 010-0874
JP021
Fukuoka, Japan, 810-8563
JP018
Hiroshima, Japan, 734-8551
JP007
Isesaki, Japan, 374-0006
JP024
Kagoshima, Japan, 892-0853
JP011
Kawasaki, Japan, 216-8511
JP015
Kobe, Japan, 650-0046
JP022
Kumamoto, Japan, 861-4193
JP012
Nagoy, Japan, 466-8650
JP026
Nishinomiya, Japan, 662-0934
JPO17
Okayama, Japan, 701-0192
JP001
Sapporo, Japan, 060-8570
JP002
Sapporo,Hokkaido, Japan, 006-8555
JP004
Sendai, Japan, 982-0012
JP005
Shibata, Japan, 989-1253
JP014
Suita, Japan, 565-8565
JP020
Tokushima, Japan, 770-8503
JP009
Tokyo, Japan, 145-0065
JP013
Toyota, Japan, 471-8513
Sponsors and Collaborators
Lundbeck Japan K. K.
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: Lundbeck Japan K. K.
ClinicalTrials.gov Identifier: NCT01104467     History of Changes
Other Study ID Numbers: 11764A
Study First Received: April 8, 2010
Last Updated: September 12, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Lundbeck Japan K. K.:
Acute Ischemic Stroke
Desmoteplase
Japan
Safety
Stroke
Tolerability

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

ClinicalTrials.gov processed this record on October 23, 2014