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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00111852
Registration number
NCT00111852
Ethics application status
Date submitted
26/05/2005
Date registered
27/05/2005
Date last updated
20/03/2012
Titles & IDs
Public title
Study of Desmoteplase (International Nonproprietary Name [INN]) in Acute Ischemic Stroke (DIAS-2)
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Scientific title
A Prospective, Randomized, Double-blind, Placebo-controlled, Single Bolus, Multinational, Multi-center, Parallel Group, Dose-ranging Study of Desmoteplase (INN) in the Indication of Acute Stroke
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Secondary ID [1]
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DSP-MD-01
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stroke, Acute
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Condition category
Condition code
Stroke
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Haemorrhagic
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Stroke
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Ischaemic
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Desmoteplase
Treatment: Drugs - Desmoteplase
Treatment: Drugs - Placebo
Experimental: Desmoteplase, low dose - Desmoteplase 90 mcg/kg, intravenous administration.
Experimental: Desmoteplase, high dose - Desmoteplase 125 mcg/kg, intravenous administration.
Placebo Comparator: Placebo - Dose-Match Placebo, intravenous administration.
Treatment: Drugs: Desmoteplase
Desmoteplase 90 mcg/kg, intravenous administration.
Treatment: Drugs: Desmoteplase
Desmoteplase 125 mcg/kg, intravenous administration.
Treatment: Drugs: Placebo
Dose-Match Placebo, intravenous administration.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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National Institutes of Health Stroke Scale (NIHSS)
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Assessment method [1]
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Improvement of greater than or equal to 8 points from baseline, or NIHSS score less than or equal to 1. The NIHSS score ranges from 0 (least severe) to 42 (more severe).
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Timepoint [1]
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Change from Baseline to day 90
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Primary outcome [2]
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Modified Rankin Scale (MRS)
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Assessment method [2]
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Improvement on the Modified Rankin Scale, defined as a score of 0-2. The MRS ranges in severity from 0 (no symptoms) to 6 (Dead).
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Timepoint [2]
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Day 90
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Primary outcome [3]
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Barthel Index (BI) score of 75-100.
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Assessment method [3]
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The Barthel Index (BI) is a scale used to measure performance in basic Activities of Daily Livingranges from 0 (most disablility) to 100 (no disability)
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Timepoint [3]
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Day 90
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Secondary outcome [1]
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Percentage of patients with improvement in NIHSS score
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Assessment method [1]
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Improvement of greater than or equal to 8 points from baseline on the NIHSS score, or NIHSS score less than or equal to 1.
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Timepoint [1]
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From Baseline to Day 90
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Secondary outcome [2]
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Percentage of patients with MRS score of 0-2
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Assessment method [2]
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Timepoint [2]
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Day 90
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Secondary outcome [3]
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Percentage of patients with BI score of 75-100
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Assessment method [3]
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Timepoint [3]
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Day 90
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Secondary outcome [4]
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Infarct Volume
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Assessment method [4]
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Timepoint [4]
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Change from baseline to Day 30
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Eligibility
Key inclusion criteria
- Eligible for study treatment within 3-9 hours after onset of stroke symptoms.
- Score of 4-24 on the NIHSS with clinical signs of hemispheric infarction (i.e.
hemiparesis) suggestive of ischemic stroke.
Inclusion Criteria from diagnostic imaging screening:
- Distinct penumbra (at least 20%), measured by MRI (PWI/DWI) or perfusion CT, related
to middle cerebral artery (MCA), anterior cerebral artery (ACA), or posterior cerebral
artery (PCA) territory in a hemispheric distribution.
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Minimum age
18
Years
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History or clinical presentation of intracranial hemorrhage (ICH), subarachnoid
hemorrhage, arteriovenous malformation, aneurysm, or cerebral neoplasm.
- Rapidly improving neurological symptoms.
- Pre-stroke MRS score of > 1 (including previous disability).
- Suspected acute vertebral or basilar artery occlusion.
- Current use of anticoagulants and a prolonged prothrombin time.
- Uncontrolled hypertension.
- Baseline hematocrit of < 0.25.
- Baseline platelet count < 100,000/mm3.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
193
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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John Hunter Hospital - New Lambton Heights
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Recruitment hospital [2]
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Box Hill Hospital - Victoria
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Recruitment hospital [3]
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Queen Elizabeth Hospital - Woodville
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Recruitment postcode(s) [1]
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NSW 2310 - New Lambton Heights
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Recruitment postcode(s) [2]
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3128 - Victoria
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Recruitment postcode(s) [3]
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SA 5011 - Woodville
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Recruitment outside Australia
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United States of America
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Alabama
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Linz
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Helsinki
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Kuopio
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Bonn
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Germany
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Leipzig
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Germany
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Ulm
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Amsterdam
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Badalona
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Spain
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Girona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Forest Laboratories
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to evaluate desmoteplase (which is a manufactured protein
derived from the saliva of the vampire bat) in dissolving clots that are blocking the flow of
blood through one (or more) of the blood vessels supplying the brain, thereby reopening the
blocked blood vessel and allowing blood to flow again in individuals suffering from ischemic
stroke.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00111852
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Leslie Lipka, MD
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Address
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Forest Laboratories
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00111852
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