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Completed

NCT Number: NCT01104467

Clinical Study of Desmoteplase in Japanese Patients With Acute Ischemic Stroke

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

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

JP006, Akita, Japan

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Desmoteplase

Drug

1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)

Placebo

Other

1 bolus injection of placebo IV

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

    Time frame: 90 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Lundbeck Japan K. K.

Industry

Registry information

Official study title

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

Acronym: DIAS-J

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 15, 2010
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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