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

August 30, 2021 updated by: Lundbeck Japan K. K.

Randomised, Double-blind, Placebo-controlled, Dose-escalation 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Akita, Japan, 010-0874
        • JP006
      • Fukuoka, Japan, 810-8563
        • JP021
      • Hiroshima, Japan, 734-8551
        • JP018
      • Isesaki, Japan, 374-0006
        • JP007
      • Kagoshima, Japan, 892-0853
        • JP024
      • Kawasaki, Japan, 216-8511
        • JP011
      • Kobe, Japan, 650-0046
        • JP015
      • Kumamoto, Japan, 861-4193
        • JP022
      • Nagoya, Japan, 466-8650
        • JP012
      • Nishinomiya, Japan, 662-0934
        • JP026
      • Okayama, Japan, 701-0192
        • JPO17
      • Sapporo, Japan, 060-8570
        • JP001
      • Sapporo,Hokkaido, Japan, 006-8555
        • JP002
      • Sendai, Japan, 982-0012
        • JP004
      • Shibata, Japan, 989-1253
        • JP005
      • Suita, Japan, 565-8565
        • JP014
      • Tokushima, Japan, 770-8503
        • JP020
      • Tokyo, Japan, 145-0065
        • JP009
      • Toyota, Japan, 471-8513
        • JP013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
90 days
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
Day 7 and Day 30
To evaluate recanalisation at 18±6 hr after administration of IMP
Time Frame: 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
Time Frame: 18±6 hr after administration
18±6 hr after administration
To evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of desmoteplase
Time Frame: 0.5 - 9 hr
0.5 - 9 hr
To evaluate the immunogenicity of desmoteplase
Time Frame: Day 7, Day 30, Day 90
Day 7, Day 30, Day 90
To explore the predictive value of different volumes of absolute mismatch for the clinical response and other objectives
Time Frame: Day 90
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lundbeck Japan K. K.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

August 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

April 8, 2010

First Submitted That Met QC Criteria

April 13, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Actual)

August 31, 2021

Last Update Submitted That Met QC Criteria

August 30, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11764A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Ischemic Stroke

Clinical Trials on Desmoteplase

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe