Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke
- Registration Number
- NCT00790920
- Lead Sponsor
- H. Lundbeck A/S
- 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.
- Detailed Description
Acute stroke is a major cause of mortality and long-term disability in the developed world. The only currently approved thrombolytic intervention for acute ischemic stroke, which constitutes the majority of strokes, is alteplase (recombinant tissue plasminogen activator; rtPA). The use of alteplase is limited as it is approved for use within 3 hours after symptom onset and by the risk of inducing intracerebral haemorrhage; consequently fewer than 3% of acute stroke subjects are treated. The thrombolytic agent desmoteplase (recombinant Desmodus Salivary Plasminogen Activator alpha-1; rDSPAalpha-1) produced by recombinant biotechnology has its naturally occurring counterpart in the saliva of the vampire bat Desmodus rotundus. Compared to alteplase, desmoteplase has a more favourable profile in terms of high fibrin specificity and non neurotoxicity.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 492
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Desmoteplase Desmoteplase -
- Primary Outcome Measures
Name Time Method Modified Rankin Scale Score 90 days
- Secondary Outcome Measures
Name Time Method National Institutes of Health Stroke Scale (NIHSS) Score 90 days
Trial Locations
- Locations (102)
AU006
๐ฆ๐บClayton, Australia
FR012
๐ซ๐ทLimoges, France
IN008
๐ฎ๐ณHyderabad, India
NL002
๐ณ๐ฑGroningen, Netherlands
PL005
๐ต๐ฑLublin, Poland
ES012
๐ช๐ธAlcazar de San Juan, Spain
TW003
๐จ๐ณKaohsiung, Taiwan
TW001
๐จ๐ณKaohsiung, Taiwan
CH001
๐จ๐ญLausanne, Switzerland
ES013
๐ช๐ธLugo, Spain
ES004
๐ช๐ธGirona, Spain
TW004
๐จ๐ณTaoyuan, Taiwan
TH001
๐น๐ญPathumthani, Thailand
VN001
๐ป๐ณHo Chi Minh City, Vietnam
AT002
๐ฆ๐นLinz, Austria
EE002
๐ช๐ชTallinn, Estonia
PL004
๐ต๐ฑGdansk, Poland
TW006
๐จ๐ณTaichung, Taiwan
TW005
๐จ๐ณTainan, Taiwan
TW002
๐จ๐ณTaipei, Taiwan
NL001
๐ณ๐ฑBreda, Netherlands
PL001
๐ต๐ฑWarszawa, Poland
TH003
๐น๐ญBangkok, Thailand
TH006
๐น๐ญBangkok, Thailand
TH002
๐น๐ญBangkok, Thailand
PH003
๐ต๐ญManila, Philippines
TH004
๐น๐ญBangkok, Thailand
VN002
๐ป๐ณHanoi, Vietnam
PH002
๐ต๐ญQuezon City, Philippines
SG002
๐ธ๐ฌSingapore, Singapore
TW009
๐จ๐ณTaipei, Taiwan
AU001
๐ฆ๐บMelbourne, Australia
AU002
๐ฆ๐บMelbourne, Australia
AU003
๐ฆ๐บNew Castle, Australia
AT003
๐ฆ๐นGraz, Austria
EE004
๐ช๐ชTallinn, Estonia
EE003
๐ช๐ชTallinn, Estonia
EE001
๐ช๐ชTartu, Estonia
FR004
๐ซ๐ทBesancon, France
FR015
๐ซ๐ทCaen, France
FR008
๐ซ๐ทMontpellier, France
FR009
๐ซ๐ทParis, France
FR016
๐ซ๐ทToulouse, France
DE001
๐ฉ๐ชDresden, Germany
DE011
๐ฉ๐ชErlangen, Germany
IN009
๐ฎ๐ณGuntur, India
IN003
๐ฎ๐ณHyderabad, India
IN007
๐ฎ๐ณLudhiana, India
SG001
๐ธ๐ฌSingapore, Singapore
ES010
๐ช๐ธAlbacete, Spain
ES007
๐ช๐ธBarcelona, Spain
ES003
๐ช๐ธBarcelona, Spain
AU004
๐ฆ๐บGosford, Australia
FR013
๐ซ๐ทBordeaux, France
FR003
๐ซ๐ทBourg-en-Bresse, France
AT004
๐ฆ๐นInnsbruck, Austria
KR006
๐ฐ๐ทBusan, Korea, Republic of
AU009
๐ฆ๐บPerth, Australia
FR014
๐ซ๐ทLille, France
AT001
๐ฆ๐นLinz, Austria
AT005
๐ฆ๐นVienna, Austria
FR010
๐ซ๐ทNice, France
DE005
๐ฉ๐ชFreiburg, Germany
DE012
๐ฉ๐ชSchweinfurt, Germany
KR011
๐ฐ๐ทDaegu, Korea, Republic of
DE019
๐ฉ๐ชJena, Germany
FR001
๐ซ๐ทParis, France
FR007
๐ซ๐ทPerpignan, France
DE003
๐ฉ๐ชLeipzig, Germany
DE022
๐ฉ๐ชLรผbeck, Germany
DE002
๐ฉ๐ชBerlin, Germany
DE020
๐ฉ๐ชHannover, Germany
DE018
๐ฉ๐ชHamburg, Germany
KR009
๐ฐ๐ทSeoul, Korea, Republic of
DE021
๐ฉ๐ชNeuruppin, Germany
DE025
๐ฉ๐ชRostock, Germany
KR012
๐ฐ๐ทSeoul, Korea, Republic of
HK002
๐ญ๐ฐHong Kong, Hong Kong
DE016
๐ฉ๐ชWurzburg, Germany
KR002
๐ฐ๐ทIn Cheon, Korea, Republic of
KR010
๐ฐ๐ทKwangju, Korea, Republic of
KR003
๐ฐ๐ทAnyang City, Korea, Republic of
KR004
๐ฐ๐ทSeoul, Korea, Republic of
IN004
๐ฎ๐ณChandigarh, India
ES006
๐ช๐ธValladolid, Spain
KR008
๐ฐ๐ทSeongnam, Korea, Republic of
KR013
๐ฐ๐ทAnsan-Si, Korea, Republic of
IN001
๐ฎ๐ณPune, India
PH001
๐ต๐ญPasig City, Philippines
KR005
๐ฐ๐ทSeoul, Korea, Republic of
KR007
๐ฐ๐ทWonju-si, Korea, Republic of
KR001
๐ฐ๐ทSeoul, Korea, Republic of
PL002
๐ต๐ฑWarszawa, Poland
PL006
๐ต๐ฑSandomierz, Poland
TW007
๐จ๐ณTaipei, Taiwan
ES005
๐ช๐ธMadrid, Spain
ES014
๐ช๐ธBilbao, Spain
TW008
๐จ๐ณTainan, Taiwan
ES011
๐ช๐ธMadrid, Spain
ES008
๐ช๐ธMadrid, Spain
TH005
๐น๐ญChiang Mai, Thailand
HK001
๐ญ๐ฐHong Kong, Hong Kong