Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)
- Registration Number
- NCT00856661
- 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 to 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 to 9 hours after onset of stroke symptoms.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 270
- Diagnosis of acute ischemic stroke
- Informed consent
- Age between 18 and 85 years
- Treatment can be initiated within 3 to 9 hours after the onset of stroke symptoms
- NIHSS Score of 4 to 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 (mRS) (Percentage of Participants With mRS Scores 0-2) Day 90 The mRS is a clinician-rated scale designed to provide a global assessment of the patients dependency after stroke. The scale consists of a single item measuring the patient's function based on the ability to perform daily activities. The patient is rated on a 7-point scale from 0 to 6, where a score of 5 corresponds to severe disability, and 6 to death. Assessment of a pre-stroke mRS score is based on an interview addressing the status of the patient prior to the stroke
- Secondary Outcome Measures
Name Time Method Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8) Day 90 Please see outcomes measure one and two for detailed description of the scales
Modified Ranking Scale Score (Using the Ordinal Scale) Day 90 Please see outcomes measure one for detailed description of the mRS scale
National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8) 90 days The NIHSS is a clinician-rated, 15-item scale designed to assess the severity of stroke-related neurological deficits: level of consciousness, eye movements, visual fields, facial symmetry, motor strength (arm and leg), coordination, sensation, language (aphasia and dysarthria), and neglect. Each item is rated on a 3-, 4-, or 5-point scale ranging from 0 (normal) to the maximum score (extremely severe symptoms). The total score of the 15 items ranges from 0 to 42, where lower scores indicate less impairment.
Trial Locations
- Locations (152)
US077
๐บ๐ธLebanon, New Hampshire, United States
US064
๐บ๐ธShreveport, Louisiana, United States
US063
๐บ๐ธFairfield, Connecticut, United States
BE006
๐ง๐ชWilrijk, Belgium
CL005
๐จ๐ฑValparaiso, Chile
IE001
๐ฎ๐ชDublin, Ireland
MX002
๐ฒ๐ฝD.f., Mexico
MX003
๐ฒ๐ฝMexico City, Mexico
MX005
๐ฒ๐ฝMonterrey Nuevo Leon, Mexico
NO003
๐ณ๐ดBergen, Norway
NO001
๐ณ๐ดOslo, Norway
NO002
๐ณ๐ดTrondheim, Norway
US100
๐บ๐ธRidgewood, New Jersey, United States
US023
๐บ๐ธPhiladelphia, Pennsylvania, United States
US044
๐บ๐ธChicago, Illinois, United States
US001
๐บ๐ธColumbus, Ohio, United States
US003
๐บ๐ธBoston, Massachusetts, United States
US112
๐บ๐ธHouston, Texas, United States
US021
๐บ๐ธHouston, Texas, United States
US031
๐บ๐ธHouston, Texas, United States
US083
๐บ๐ธDetroit, Michigan, United States
US053
๐บ๐ธPhoenix, Arizona, United States
US066
๐บ๐ธDetroit, Michigan, United States
US096
๐บ๐ธDetroit, Michigan, United States
US084
๐บ๐ธPittsburg, Pennsylvania, United States
US008
๐บ๐ธLos Angeles, California, United States
US020
๐บ๐ธPalo Alto, California, United States
US050
๐บ๐ธPasadena, California, United States
US088
๐บ๐ธOak Lawn, Illinois, United States
US049
๐บ๐ธPensacola, Florida, United States
US091
๐บ๐ธMaywood, Illinois, United States
US074
๐บ๐ธEvanston, Illinois, United States
US089
๐บ๐ธLa Jolla, California, United States
US109
๐บ๐ธAtlanta, Georgia, United States
US043
๐บ๐ธLoma Linda, California, United States
US093
๐บ๐ธChicago, Illinois, United States
US052
๐บ๐ธColumbus, Georgia, United States
US042
๐บ๐ธAugusta, Georgia, United States
US085
๐บ๐ธSavannah, Georgia, United States
US051
๐บ๐ธThousand Oaks, California, United States
US098
๐บ๐ธSanta Barbara, California, United States
US067
๐บ๐ธMacon, Georgia, United States
US101
๐บ๐ธChicago, Illinois, United States
US072
๐บ๐ธDes Moines, Iowa, United States
US014
๐บ๐ธBaltimore, Maryland, United States
US062
๐บ๐ธColumbus, Ohio, United States
US048
๐บ๐ธSpringfield, Missouri, United States
US039
๐บ๐ธBoston, Massachusetts, United States
US059
๐บ๐ธGulfport, Mississippi, United States
US017
๐บ๐ธWorcester, Massachusetts, United States
US038
๐บ๐ธCleveland, Ohio, United States
US113
๐บ๐ธRoyal Oak, Michigan, United States
US060
๐บ๐ธGrand Blanc, Michigan, United States
US103
๐บ๐ธKalamazoo, Michigan, United States
US056
๐บ๐ธPetoskey, Michigan, United States
US082
๐บ๐ธSouthfield, Michigan, United States
US075
๐บ๐ธAlbany, New York, United States
US037
๐บ๐ธGreensboro, North Carolina, United States
US055
๐บ๐ธEdison, New Jersey, United States
US026
๐บ๐ธStony Brook, New York, United States
US092
๐บ๐ธProvidence, Rhode Island, United States
US070
๐บ๐ธAllentown, Pennsylvania, United States
US099
๐บ๐ธPittsburg, Pennsylvania, United States
BR012
๐ง๐ทCampinas, Brazil
BE008
๐ง๐ชBrugge, Belgium
CL003
๐จ๐ฑSantiago, Chile
CA007
๐จ๐ฆOttawa, Canada
BR008
๐ง๐ทPorto Alegre, Brazil
CL006
๐จ๐ฑSantiago, Chile
FI001
๐ซ๐ฎHelsinki, Finland
FI002
๐ซ๐ฎTampere, Finland
BR006
๐ง๐ทSalvador, Brazil
DK004
๐ฉ๐ฐCopenhagen NV, Denmark
IT008
๐ฎ๐นBrescia, Italy
IT004
๐ฎ๐นImperia, Italy
BR009
๐ง๐ทRio de Janeiro, Brazil
CA006
๐จ๐ฆHalifax, Canada
GB011
๐ฌ๐งLiverpool, United Kingdom
GB014
๐ฌ๐งSheffield, United Kingdom
BR011
๐ง๐ทRio de Janeiro, Brazil
CA002
๐จ๐ฆToronto, Canada
FI003
๐ซ๐ฎTurku, Finland
DK002
๐ฉ๐ฐAalborg, Denmark
DK001
๐ฉ๐ฐAarhus, Denmark
IT010
๐ฎ๐นAncona, Italy
IT003
๐ฎ๐นFirenze, Italy
IT006
๐ฎ๐นMilano, Italy
IT009
๐ฎ๐นMilano, Italy
IT012
๐ฎ๐นModena, Italy
ZA002
๐ฟ๐ฆCape Town, South Africa
DK003
๐ฉ๐ฐGlostrup, Denmark
IT002
๐ฎ๐นMilano, Italy
IT001
๐ฎ๐นRome, Italy
ZA003
๐ฟ๐ฆCape Town, South Africa
MX004
๐ฒ๐ฝMexico City, Mexico
SE002
๐ธ๐ชLund, Sweden
GB009
๐ฌ๐งGlasgow, United Kingdom
ZA001
๐ฟ๐ฆCape Town, South Africa
GB010
๐ฌ๐งDundee, United Kingdom
GB004
๐ฌ๐งChristchurch, United Kingdom
GB002
๐ฌ๐งExeter, United Kingdom
GB016
๐ฌ๐งNottingham, United Kingdom
GB003
๐ฌ๐งLondon, United Kingdom
GB013
๐ฌ๐งWolverhampton, United Kingdom
SE001
๐ธ๐ชMalmรธ, Sweden
US097
๐บ๐ธMilwaukee, Wisconsin, United States
IT005
๐ฎ๐นRome, Italy
IT011
๐ฎ๐นVerona, Italy
GB007
๐ฌ๐งGlasgow, United Kingdom
GB001
๐ฌ๐งNewcastle upon Tyne, United Kingdom
GB005
๐ฌ๐งStoke on Trent, United Kingdom
GB015
๐ฌ๐งWestcliff-on-Sea, United Kingdom
BR007
๐ง๐ทPorto Alegre, Brazil
US073
๐บ๐ธGlenview, Illinois, United States
US016
๐บ๐ธIndianapolis, Indiana, United States
US069
๐บ๐ธWinston-Salem, North Carolina, United States
US081
๐บ๐ธCastro Valley, California, United States
US068
๐บ๐ธEnglewood, Colorado, United States
US080
๐บ๐ธDecatur, Georgia, United States
US086
๐บ๐ธSavannah, Georgia, United States
US040
๐บ๐ธLawrenceville, Georgia, United States
US079
๐บ๐ธTroy, Michigan, United States
US102
๐บ๐ธBrooklyn, New York, United States
US078
๐บ๐ธGrand Rapids, Michigan, United States
US076
๐บ๐ธSouthfield, Michigan, United States
US012
๐บ๐ธBuffalo, New York, United States
US046
๐บ๐ธToledo, Ohio, United States
US095
๐บ๐ธSpringfield, Oregon, United States
US087
๐บ๐ธWarwick, Rhode Island, United States
US058
๐บ๐ธNashville, Tennessee, United States
US006
๐บ๐ธWinchester, Virginia, United States
US011
๐บ๐ธMadison, Wisconsin, United States
BE005
๐ง๐ชRoeselare, Belgium
BE004
๐ง๐ชHasselt, Belgium
CA004
๐จ๐ฆEdmonton, Canada
BR004
๐ง๐ทPorto Alegre, Brazil
CA005
๐จ๐ฆVictoria, Canada
CA008
๐จ๐ฆMississauga, Canada
CA001
๐จ๐ฆCalgary, Alberta, Canada
CA012
๐จ๐ฆToronto, Canada
CL002
๐จ๐ฑSantiago, Chile
GB012
๐ฌ๐งBelfast, United Kingdom
CL004
๐จ๐ฑSantiago, Chile
IT007
๐ฎ๐นRozzano, Italy
GB006
๐ฌ๐งLondon, United Kingdom
US057
๐บ๐ธColumbia, South Carolina, United States
US115
๐บ๐ธNeptune, New Jersey, United States
US019
๐บ๐ธChattanooga, Tennessee, United States
US104
๐บ๐ธNew Haven, Connecticut, United States
US061
๐บ๐ธNew Orleans, Louisiana, United States
US108
๐บ๐ธNew Orleans, Louisiana, United States
US047
๐บ๐ธRichmond, Virginia, United States