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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00790920




Registration number
NCT00790920
Ethics application status
Date submitted
13/11/2008
Date registered
14/11/2008
Date last updated
18/09/2015

Titles & IDs
Public title
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke
Scientific title
A Randomised, Double-blind, Parallel-group Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Desmoteplase in Subjects With Acute Ischemic Stroke
Secondary ID [1] 0 0
2008-000622-40
Secondary ID [2] 0 0
12402A
Universal Trial Number (UTN)
Trial acronym
DIAS-3
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 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 - Placebo

Experimental: Desmoteplase -

Placebo comparator: Placebo -


Treatment: Drugs: Desmoteplase
90 µg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day

Treatment: Drugs: Placebo
IV, single bolus over 1 - 2 minutes on 1st day
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Rankin Scale Score
Timepoint [1] 0 0
90 days
Secondary outcome [1] 0 0
National Institutes of Health Stroke Scale (NIHSS) Score
Timepoint [1] 0 0
90 days

Eligibility
Key inclusion criteria
* Diagnosis of acute ischemic stroke
* Informed consent
* Age between 18 and 85 years
* Treatment can be initiated within 3-9 hours after the onset of stroke symptoms
* NIHSS Score of 4-24
* Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Pre-stroke mRS >1
* Previous exposure to desmoteplase
* Extensive early infarction on MRI or CT in any affected area
* Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral neoplasm
* Internal carotid artery occlusion on the side of the stroke lesion
* Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin time
* Treatment with oral anticoagulants and a prolonged prothrombin time
* Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of single agent oral platelet inhibitors is permitted
* Treatment with a thrombolytic agent within the past 72 hours

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 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
1/12/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
492
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
AU006 - Clayton
Recruitment hospital [2] 0 0
AU004 - Gosford
Recruitment hospital [3] 0 0
AU001 - Melbourne
Recruitment hospital [4] 0 0
AU002 - Melbourne
Recruitment hospital [5] 0 0
AU003 - New Castle
Recruitment hospital [6] 0 0
AU009 - Perth
Recruitment postcode(s) [1] 0 0
3168 - Clayton
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
- Melbourne
Recruitment postcode(s) [4] 0 0
- New Castle
Recruitment postcode(s) [5] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Innsbruck
Country [3] 0 0
Austria
State/province [3] 0 0
Linz
Country [4] 0 0
Austria
State/province [4] 0 0
Vienna
Country [5] 0 0
Estonia
State/province [5] 0 0
Tallinn
Country [6] 0 0
Estonia
State/province [6] 0 0
Tartu
Country [7] 0 0
France
State/province [7] 0 0
Besancon
Country [8] 0 0
France
State/province [8] 0 0
Bordeaux
Country [9] 0 0
France
State/province [9] 0 0
Bourg-en-Bresse
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France
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Caen
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France
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Lille
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France
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Limoges
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France
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Montpellier
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France
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Nice
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France
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Paris
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France
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Perpignan
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France
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Toulouse
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Germany
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Berlin
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Jena
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Germany
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Leipzig
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Germany
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Lübeck
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Germany
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Neuruppin
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Germany
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Rostock
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Germany
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Schweinfurt
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Germany
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Wurzburg
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Hong Kong
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Hong Kong
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India
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Chandigarh
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India
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Guntur
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India
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Hyderabad
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India
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Ludhiana
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India
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Pune
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Korea, Republic of
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Ansan-Si
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Korea, Republic of
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Anyang City
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Korea, Republic of
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Busan
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Korea, Republic of
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Daegu
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Korea, Republic of
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In Cheon
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Korea, Republic of
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Kwangju
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Korea, Republic of
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Seongnam
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Korea, Republic of
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Seoul
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Korea, Republic of
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Wonju-si
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Netherlands
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Breda
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Netherlands
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Groningen
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Philippines
State/province [48] 0 0
Manila
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Philippines
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Pasig City
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Philippines
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Quezon City
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Poland
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Gdansk
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Poland
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Lublin
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Poland
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Sandomierz
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Poland
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Warszawa
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Singapore
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Singapore
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Spain
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Albacete
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Spain
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Alcazar de San Juan
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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Girona
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Valladolid
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Switzerland
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Lausanne
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Taiwan
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Kaohsiung
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiang Mai
Country [72] 0 0
Thailand
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Pathumthani
Country [73] 0 0
Vietnam
State/province [73] 0 0
Hanoi
Country [74] 0 0
Vietnam
State/province [74] 0 0
Ho Chi Minh City

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
H. Lundbeck A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine whether desmoteplase is effective and safe in the treatment of patients with acute ischaemic stroke when given within 3-9 hours from onset of stroke symptoms.
Trial website
https://clinicaltrials.gov/study/NCT00790920
Trial related presentations / publications
Albers GW, von Kummer R, Truelsen T, Jensen JK, Ravn GM, Gronning BA, Chabriat H, Chang KC, Davalos AE, Ford GA, Grotta J, Kaste M, Schwamm LH, Shuaib A; DIAS-3 Investigators. Safety and efficacy of desmoteplase given 3-9 h after ischaemic stroke in patients with occlusion or high-grade stenosis in major cerebral arteries (DIAS-3): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Neurol. 2015 Jun;14(6):575-84. doi: 10.1016/S1474-4422(15)00047-2. Epub 2015 Apr 30.
Public notes

Contacts
Principal investigator
Name 0 0
Email contact via H. Lundbeck A/S
Address 0 0
[email protected]
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00790920