Trial record 1 of 83 for:    DIAS 4
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Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

This study has been terminated.
(The recruitment into DIAS4 has been stopped as the result of DIAS 3 indicates that the study is unlikely to reach its primary endpoint with the current protocol)
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00856661
First received: March 5, 2009
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Stroke
Drug: Desmoteplase
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Modified Rankin Scale Score [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • National Institutes of Health Stroke Scale (NIHSS) Score [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 257
Study Start Date: April 2009
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Desmoteplase Drug: Desmoteplase
90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day
Placebo Comparator: Placebo Drug: Placebo
IV, single bolus over 1 to 2 minutes on 1st day

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00856661

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Locations
United States, Arizona
US053
Phoenix, Arizona, United States, 85054
United States, California
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Castro Valley, California, United States, 94546
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La Jolla, California, United States, 92037
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Loma Linda, California, United States, 92354
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Los Angeles, California, United States, 90024-1777
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Palo Alto, California, United States, 94304
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Pasadena, California, United States, 91105
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Thousand Oaks, California, United States, 91360
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Englewood, Colorado, United States, 80113
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Fairfield, Connecticut, United States, 06824
US104
New Haven, Connecticut, United States, 06510
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US049
Pensacola, Florida, United States, 32504
United States, Georgia
US109
Atlanta, Georgia, United States, 30303
US042
Augusta, Georgia, United States, 30912
US052
Columbus, Georgia, United States, 31902
US080
Decatur, Georgia, United States, 30033
US040
Lawrenceville, Georgia, United States, 30045
US067
Macon, Georgia, United States, 31201
US085
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US086
Savannah, Georgia, United States, 31419
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Chicago, Illinois, United States, 60622
US093
Chicago, Illinois, United States, 60611
US101
Chicago, Illinois, United States, 60612
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US064
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US014
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US003
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Detroit, Michigan, United States, 48201
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Springfield, Missouri, United States, 65807
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US077
Lebanon, New Hampshire, United States, 03756
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US055
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US100
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Albany, New York, United States, 12208
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Cleveland, Ohio, United States, 44109
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Richmond, Virginia, United States, 23298
US006
Winchester, Virginia, United States, 22601
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Madison, Wisconsin, United States, 53792
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Milwaukee, Wisconsin, United States, 53226
Belgium
BE008
Brugge, Belgium, 8000
BE004
Hasselt, Belgium, 3500
BE005
Roeselare, Belgium, 8800
BE006
Wilrijk, Belgium, 2610
Brazil
BR012
Campinas, Brazil, 13083-970
BR008
Porto Alegre, Brazil, 90035-003
BR004
Porto Alegre, Brazil, 90020-090
BR007
Porto Alegre, Brazil, 90110-270
BR009
Rio de Janeiro, Brazil, 20941-150
BR011
Rio de Janeiro, Brazil, 22280-000
BR006
Salvador, Brazil, 40140-110
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CA001
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Canada
CA004
Edmonton, Canada, T6L 5X8
CA006
Halifax, Canada, B3H 3A7
CA008
Mississauga, Canada, L5B 1B8
CA007
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CA002
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CA012
Toronto, Canada, M4N 3M5
CA005
Victoria, Canada, V8R 1J8
Chile
CL003
Santiago, Chile
CL004
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CL006
Santiago, Chile
CL002
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CL005
Valparaiso, Chile
Denmark
DK002
Aalborg, Denmark, 9000
DK001
Aarhus, Denmark, 8000
DK004
Copenhagen NV, Denmark, 2400
DK003
Glostrup, Denmark, 2600
Finland
FI001
Helsinki, Finland, 29
FI002
Tampere, Finland, 33520
FI003
Turku, Finland, 20520
Ireland
IE001
Dublin, Ireland, 8
Italy
IT010
Ancona, Italy, 60020
IT008
Brescia, Italy, 25123
IT003
Firenze, Italy, 50019
IT004
Imperia, Italy, 18100
IT009
Milano, Italy, 20162
IT002
Milano, Italy, 20132
IT006
Milano, Italy, 20153
IT012
Modena, Italy, 41100
IT001
Rome, Italy, 161
IT005
Rome, Italy, 189
IT007
Rozzano, Italy, 20089
IT011
Verona, Italy, 37126
Mexico
MX002
D.f., Mexico, 14269
MX003
Mexico City, Mexico, 14000
MX004
Mexico City, Mexico, 14050
MX005
Monterrey Nuevo Leon, Mexico
Norway
NO003
Bergen, Norway, 2021
NO001
Oslo, Norway, 0027
NO002
Trondheim, Norway, 7006
South Africa
ZA001
Cape Town, South Africa, 7800
ZA003
Cape Town, South Africa, 7130
ZA002
Cape Town, South Africa, 7405
Sweden
SE002
Lund, Sweden, 221 85
SE001
Malmø, Sweden, 205 02
United Kingdom
GB012
Belfast, United Kingdom, BT12 6BJ
GB004
Christchurch, United Kingdom, BH23 2JX
GB010
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GB002
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GB007
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GB009
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GB011
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GB003
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GB006
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GB001
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GB016
Nottingham, United Kingdom, NG5 1PB
GB014
Sheffield, United Kingdom, S10 2JF
GB005
Stoke on Trent, United Kingdom, ST4 6QG
GB015
Westcliff-on-Sea, United Kingdom, SS0 0RY
GB013
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
  More Information

No publications provided

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT00856661     History of Changes
Other Study ID Numbers: 12649A, 2008-005539-14
Study First Received: March 5, 2009
Last Updated: October 8, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: Ministry of Health
Canada: Health Canada
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Mexico: Ministry of Health
Norway: Norwegian Medicines Agency
South Africa: Medicines Control Council
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

Keywords provided by H. Lundbeck A/S:
Acute ischemic stroke
Angiography
Desmoteplase
Thrombolytic

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Salivary plasminogen activator alpha 1, Desmodus rotundus
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014