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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
Timepoint [1] 0 0
Change from Baseline to day 90
Primary outcome [2] 0 0
Modified Rankin Scale (MRS)
Timepoint [2] 0 0
Day 90
Primary outcome [3] 0 0
Barthel Index (BI) score of 75-100.
Timepoint [3] 0 0
Day 90
Secondary outcome [1] 0 0
Percentage of patients with improvement in NIHSS score
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
Sex
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
1/04/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
193
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
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Tennessee
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00111852