Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke
NCT ID: NCT00790920
Last Updated: 2015-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
492 participants
INTERVENTIONAL
2008-12-31
Brief Summary
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Detailed Description
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The study aims to confirm efficacy and safety of desmoteplase for thrombolytic therapy of patients with acute ischaemic stroke in the extended time window of 3-9 hours after onset of stroke symptoms.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Desmoteplase
Desmoteplase
90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day
Placebo
Placebo
IV, single bolus over 1 - 2 minutes on 1st day
Interventions
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Desmoteplase
90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day
Placebo
IV, single bolus over 1 - 2 minutes on 1st day
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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H. Lundbeck A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Locations
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AU006
Clayton, , Australia
AU004
Gosford, , Australia
AU001
Melbourne, , Australia
AU002
Melbourne, , Australia
AU003
Newcastle, , Australia
AU009
Perth, , Australia
AT003
Graz, , Austria
AT004
Innsbruck, , Austria
AT002
Linz, , Austria
AT001
Linz, , Austria
AT005
Vienna, , Austria
EE002
Tallinn, , Estonia
EE004
Tallinn, , Estonia
EE003
Tallinn, , Estonia
EE001
Tartu, , Estonia
FR004
Besançon, , France
FR013
Bordeaux, , France
FR003
Bourg-en-Bresse, , France
FR015
Caen, , France
FR014
Lille, , France
FR012
Limoges, , France
FR008
Montpellier, , France
FR010
Nice, , France
FR001
Paris, , France
FR009
Paris, , France
FR007
Perpignan, , France
FR016
Toulouse, , France
DE002
Berlin, , Germany
DE001
Dresden, , Germany
DE011
Erlangen, , Germany
DE005
Freiburg im Breisgau, , Germany
DE018
Hamburg, , Germany
DE020
Hanover, , Germany
DE019
Jena, , Germany
DE003
Leipzig, , Germany
DE022
Lübeck, , Germany
DE021
Neuruppin, , Germany
DE025
Rostock, , Germany
DE012
Schweinfurt, , Germany
DE016
Würzburg, , Germany
HK001
Hong Kong, , Hong Kong
HK002
Hong Kong, , Hong Kong
IN004
Chandigarh, , India
IN009
Guntur, , India
IN008
Hyderabad, , India
IN003
Hyderabad, , India
IN007
Ludhiana, , India
IN001
Pune, , India
NL001
Breda, , Netherlands
NL002
Groningen, , Netherlands
PH003
Manila, , Philippines
PH001
Pasig, , Philippines
PH002
Quezon City, , Philippines
PL004
Gdansk, , Poland
PL005
Lublin, , Poland
PL006
Sandomierz, , Poland
PL001
Warsaw, , Poland
PL002
Warsaw, , Poland
SG002
Singapore, , Singapore
SG001
Singapore, , Singapore
KR013
Ansan-si, , South Korea
KR003
Anyang, , South Korea
KR006
Busan, , South Korea
KR011
Daegu, , South Korea
KR002
Incheon, , South Korea
KR010
Kwangju, , South Korea
KR008
Seongnam, , South Korea
KR004
Seoul, , South Korea
KR001
Seoul, , South Korea
KR012
Seoul, , South Korea
KR009
Seoul, , South Korea
KR005
Seoul, , South Korea
KR007
Wŏnju, , South Korea
ES010
Albacete, , Spain
ES012
Alcázar de San Juan, , Spain
ES007
Barcelona, , Spain
ES003
Barcelona, , Spain
ES014
Bilbao, , Spain
ES004
Girona, , Spain
ES013
Lugo, , Spain
ES011
Madrid, , Spain
ES005
Madrid, , Spain
ES008
Madrid, , Spain
ES006
Valladolid, , Spain
CH001
Lausanne, , Switzerland
TW003
Kaohsiung City, , Taiwan
TW001
Kaohsiung City, , Taiwan
TW006
Taichung, , Taiwan
TW005
Tainan City, , Taiwan
TW008
Tainan City, , Taiwan
TW009
Taipei, , Taiwan
TW007
Taipei, , Taiwan
TW002
Taipei, , Taiwan
TW004
Taoyuan District, , Taiwan
TH003
Bangkok, , Thailand
TH002
Bangkok, , Thailand
TH006
Bangkok, , Thailand
TH004
Bangkok, , Thailand
TH005
Chiang Mai, , Thailand
TH001
Pathum Thani, , Thailand
VN002
Hanoi, , Vietnam
VN001
Ho Chi Minh City, , Vietnam
Countries
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References
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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.
Related Links
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EMA EudraCT Result Posting
Other Identifiers
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2008-000622-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
12402A
Identifier Type: -
Identifier Source: org_study_id
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