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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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)
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
Secondary ID [1] 0 0
DSP-MD-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke, Acute 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
National Institutes of Health Stroke Scale (NIHSS) - 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).
Timepoint [1] 0 0
Change from Baseline to day 90
Primary outcome [2] 0 0
Modified Rankin Scale (MRS) - 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).
Timepoint [2] 0 0
Day 90
Primary outcome [3] 0 0
Barthel Index (BI) score of 75-100. - 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)
Timepoint [3] 0 0
Day 90
Secondary outcome [1] 0 0
Percentage of patients with improvement in NIHSS score - Improvement of greater than or equal to 8 points from baseline on the NIHSS score, or NIHSS score less than or equal to 1.
Timepoint [1] 0 0
From Baseline to Day 90
Secondary outcome [2] 0 0
Percentage of patients with MRS score of 0-2
Timepoint [2] 0 0
Day 90
Secondary outcome [3] 0 0
Percentage of patients with BI score of 75-100
Timepoint [3] 0 0
Day 90
Secondary outcome [4] 0 0
Infarct Volume
Timepoint [4] 0 0
Change from baseline to Day 30

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.
Minimum age
18 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton Heights
Recruitment hospital [2] 0 0
Box Hill Hospital - Victoria
Recruitment hospital [3] 0 0
Queen Elizabeth Hospital - Woodville
Recruitment postcode(s) [1] 0 0
NSW 2310 - New Lambton Heights
Recruitment postcode(s) [2] 0 0
3128 - Victoria
Recruitment postcode(s) [3] 0 0
SA 5011 - Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Kentucky
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Nevada
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United States of America
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New Jersey
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United States of America
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North Carolina
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United States of America
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Ohio
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United States of America
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Tennessee
Country [14] 0 0
United States of America
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Texas
Country [15] 0 0
United States of America
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Utah
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Wisconsin
Country [18] 0 0
Austria
State/province [18] 0 0
Graz
Country [19] 0 0
Austria
State/province [19] 0 0
Innsbruck
Country [20] 0 0
Austria
State/province [20] 0 0
Linz
Country [21] 0 0
Canada
State/province [21] 0 0
Alberta
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Finland
State/province [23] 0 0
Helsinki
Country [24] 0 0
Finland
State/province [24] 0 0
Kuopio
Country [25] 0 0
Germany
State/province [25] 0 0
Bonn
Country [26] 0 0
Germany
State/province [26] 0 0
Leipzig
Country [27] 0 0
Germany
State/province [27] 0 0
Ulm
Country [28] 0 0
Netherlands
State/province [28] 0 0
Amsterdam
Country [29] 0 0
Spain
State/province [29] 0 0
Badalona
Country [30] 0 0
Spain
State/province [30] 0 0
Girona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Forest Laboratories
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00111852
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Leslie Lipka, MD
Address 0 0
Forest Laboratories
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications