Trial record 2 of 6 for:    Desmoteplase in subjects with Acute Ischemic Stroke

Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by H. Lundbeck A/S
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00856661
First received: March 5, 2009
Last updated: May 14, 2014
Last verified: May 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 ]

Estimated Enrollment: 400
Study Start Date: April 2009
Estimated Primary Completion Date: January 2015 (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

Contacts
Contact: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

  Hide Study Locations
Locations
United States, Arizona
US053 Terminated
Phoenix, Arizona, United States, 85054
United States, California
US081 Terminated
Castro Valley, California, United States, 94546
US089 Not yet recruiting
La Jolla, California, United States, 92037
US043 Completed
Loma Linda, California, United States, 92354
US008 Not yet recruiting
Los Angeles, California, United States, 90024-1777
US020 Not yet recruiting
Palo Alto, California, United States, 94304
US050 Recruiting
Pasadena, California, United States, 91105
US098 Not yet recruiting
Santa Barbara, California, United States, 93105
US051 Not yet recruiting
Thousand Oaks, California, United States, 91360
United States, Colorado
US068 Terminated
Englewood, Colorado, United States, 80113
United States, Connecticut
US063 Not yet recruiting
Fairfield, Connecticut, United States, 06824
US104 Not yet recruiting
New Haven, Connecticut, United States, 06510
United States, Florida
US049 Terminated
Pensacola, Florida, United States, 32504
United States, Georgia
US109 Recruiting
Atlanta, Georgia, United States, 30303
US042 Recruiting
Augusta, Georgia, United States, 30912
US052 Not yet recruiting
Columbus, Georgia, United States, 31902
US080 Terminated
Decatur, Georgia, United States, 30033
US040 Terminated
Lawrenceville, Georgia, United States, 30045
US067 Terminated
Macon, Georgia, United States, 31201
US086 Completed
Savannah, Georgia, United States, 31419
US085 Terminated
Savannah, Georgia, United States, 31405
United States, Illinois
US044 Not yet recruiting
Chicago, Illinois, United States, 60622
US093 Terminated
Chicago, Illinois, United States, 60611
US101 Not yet recruiting
Chicago, Illinois, United States, 60612
US074 Recruiting
Evanston, Illinois, United States, 60201
US073 Not yet recruiting
Glenview, Illinois, United States, 60026
US091 Not yet recruiting
Maywood, Illinois, United States, 60153
US088 Completed
Oak Lawn, Illinois, United States, 60453
United States, Indiana
US016 Recruiting
Indianapolis, Indiana, United States, 46260
United States, Iowa
US072 Recruiting
Des Moines, Iowa, United States, 50314-2611
United States, Louisiana
US061 Not yet recruiting
New Orleans, Louisiana, United States, 70112
US108 Not yet recruiting
New Orleans, Louisiana, United States, 70121
US064 Not yet recruiting
Shreveport, Louisiana, United States, 71130-3932
United States, Maryland
US014 Recruiting
Baltimore, Maryland, United States, 21231
United States, Massachusetts
US003 Recruiting
Boston, Massachusetts, United States, 02118
US039 Recruiting
Boston, Massachusetts, United States, 02114
US017 Completed
Worcester, Massachusetts, United States, 01605
United States, Michigan
US096 Not yet recruiting
Detroit, Michigan, United States, 48202
US066 Terminated
Detroit, Michigan, United States, 48201
US083 Not yet recruiting
Detroit, Michigan, United States, 48236
US060 Completed
Grand Blanc, Michigan, United States, 48439
US078 Recruiting
Grand Rapids, Michigan, United States, 49503
US103 Not yet recruiting
Kalamazoo, Michigan, United States, 49007
US056 Terminated
Petoskey, Michigan, United States, 49770
US113 Not yet recruiting
Royal Oak, Michigan, United States, 48073
US113 Recruiting
Royal Oak, Michigan, United States, 48073
US076 Not yet recruiting
Southfield, Michigan, United States, 48075
US082 Not yet recruiting
Southfield, Michigan, United States, 48075
US079 Not yet recruiting
Troy, Michigan, United States, 48085
United States, Mississippi
US059 Terminated
Gulfport, Mississippi, United States, 39502
United States, Missouri
US048 Terminated
Springfield, Missouri, United States, 65807
United States, New Hampshire
US077 Recruiting
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
US055 Recruiting
Edison, New Jersey, United States, 08818
US115 Not yet recruiting
Neptune, New Jersey, United States, 07753
US100 Recruiting
Ridgewood, New Jersey, United States, 07450
United States, New York
US075 Recruiting
Albany, New York, United States, 12208
US102 Not yet recruiting
Brooklyn, New York, United States, 11220
US012 Recruiting
Buffalo, New York, United States, 14203
US026 Terminated
Stony Brook, New York, United States, 11794-8121
United States, North Carolina
US037 Recruiting
Greensboro, North Carolina, United States, 27401
US069 Terminated
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
US038 Terminated
Cleveland, Ohio, United States, 44109
US062 Terminated
Columbus, Ohio, United States, 43214
US001 Not yet recruiting
Columbus, Ohio, United States, 43210
US046 Not yet recruiting
Toledo, Ohio, United States, 43614
United States, Oregon
US095 Not yet recruiting
Springfield, Oregon, United States, 97477
United States, Pennsylvania
US070 Terminated
Allentown, Pennsylvania, United States, 18103
US023 Not yet recruiting
Philadelphia, Pennsylvania, United States, 19141
US084 Recruiting
Pittsburg, Pennsylvania, United States, 15213
US099 Not yet recruiting
Pittsburg, Pennsylvania, United States, 15212
United States, Rhode Island
US092 Terminated
Providence, Rhode Island, United States, 02903
US087 Not yet recruiting
Warwick, Rhode Island, United States, 02886
United States, South Carolina
US057 Recruiting
Columbia, South Carolina, United States, 29203
United States, Tennessee
US019 Recruiting
Chattanooga, Tennessee, United States, 37403
US058 Recruiting
Nashville, Tennessee, United States, 37205
United States, Texas
US021 Recruiting
Houston, Texas, United States, 77030
US031 Terminated
Houston, Texas, United States, 77030
US112 Not yet recruiting
Houston, Texas, United States, 77030
United States, Virginia
US047 Terminated
Richmond, Virginia, United States, 23298
US006 Completed
Winchester, Virginia, United States, 22601
United States, Wisconsin
US011 Completed
Madison, Wisconsin, United States, 53792
US097 Recruiting
Milwaukee, Wisconsin, United States, 53226
Belgium
BE008 Not yet recruiting
Brugge, Belgium, 8000
BE004 Terminated
Hasselt, Belgium, 3500
BE005 Terminated
Roeselare, Belgium, 8800
BE006 Terminated
Wilrijk, Belgium, 2610
Brazil
BR012 Recruiting
Campinas, Brazil, 13083-970
BR008 Recruiting
Porto Alegre, Brazil, 90035-003
BR007 Recruiting
Porto Alegre, Brazil, 90110-270
BR004 Terminated
Porto Alegre, Brazil, 90020-090
BR009 Recruiting
Rio de Janeiro, Brazil, 20941-150
BR011 Recruiting
Rio de Janeiro, Brazil, 22280-000
BR006 Recruiting
Salvador, Brazil, 40140-110
Canada, Alberta
CA001 Recruiting
Calgary, Alberta, Canada, T2N 2T9
Canada
CA004 Recruiting
Edmonton, Canada, T6L 5X8
CA006 Terminated
Halifax, Canada, B3H 3A7
CA008 Not yet recruiting
Mississauga, Canada, L5B 1B8
CA007 Not yet recruiting
Ottawa, Canada, K1Y 4E9
CA002 Recruiting
Toronto, Canada, M5T 2S8
CA012 Recruiting
Toronto, Canada, M4N 3M5
CA005 Recruiting
Victoria, Canada, V8R 1J8
Chile
CL003 Terminated
Santiago, Chile
CL006 Terminated
Santiago, Chile
CL002 Completed
Santiago, Chile
CL004 Completed
Santiago, Chile
CL005 Completed
Valparaiso, Chile
Denmark
DK002 Completed
Aalborg, Denmark, 9000
DK001 Recruiting
Aarhus, Denmark, 8000
DK004 Recruiting
Copenhagen NV, Denmark, 2400
DK003 Completed
Glostrup, Denmark, 2600
Finland
FI001 Recruiting
Helsinki, Finland, 29
FI002 Terminated
Tampere, Finland, 33520
FI003 Recruiting
Turku, Finland, 20520
Ireland
IE001 Terminated
Dublin, Ireland, 8
Italy
IT010 Completed
Ancona, Italy, 60020
IT008 Completed
Brescia, Italy, 25123
IT003 Completed
Firenze, Italy, 50019
IT004 Recruiting
Imperia, Italy, 18100
IT002 Completed
Milano, Italy, 20132
IT006 Completed
Milano, Italy, 20153
IT009 Completed
Milano, Italy, 20162
IT012 Recruiting
Modena, Italy, 41100
IT001 Recruiting
Rome, Italy, 161
IT005 Recruiting
Rome, Italy, 189
IT007 Completed
Rozzano, Italy, 20089
IT011 Recruiting
Verona, Italy, 37126
Mexico
MX002 Recruiting
D.f., Mexico, 14269
MX003 Recruiting
Mexico City, Mexico, 14000
MX004 Active, not recruiting
Mexico City, Mexico, 14050
MX005 Recruiting
Monterrey Nuevo Leon, Mexico
Norway
NO003 Completed
Bergen, Norway, 2021
NO001 Completed
Oslo, Norway, 0027
NO002 Completed
Trondheim, Norway, 7006
South Africa
ZA001 Terminated
Cape Town, South Africa, 7800
ZA002 Completed
Cape Town, South Africa, 7405
ZA003 Terminated
Cape Town, South Africa, 7130
Sweden
SE002 Completed
Lund, Sweden, 221 85
SE001 Completed
Malmø, Sweden, 205 02
United Kingdom
GB012 Not yet recruiting
Belfast, United Kingdom, BT12 6BJ
GB004 Recruiting
Christchurch, United Kingdom, BH23 2JX
GB010 Recruiting
Dundee, United Kingdom, DD1 9SY
GB002 Recruiting
Exeter, United Kingdom, EX2 5DW
GB007 Recruiting
Glasgow, United Kingdom, G51 4TF
GB009 Recruiting
Glasgow, United Kingdom, G11 6NT
GB011 Recruiting
Liverpool, United Kingdom, L7 8XP
GB003 Recruiting
London, United Kingdom, SW17 0RE
GB006 Recruiting
London, United Kingdom, SE5 8AF
GB001 Recruiting
Newcastle upon Tyne, United Kingdom, NE1 4LP
GB016 Not yet recruiting
Nottingham, United Kingdom, NG5 1PB
GB014 Not yet recruiting
Sheffield, United Kingdom, S10 2JF
GB005 Recruiting
Stoke on Trent, United Kingdom, ST4 6QG
GB015 Recruiting
Westcliff-on-Sea, United Kingdom, SS0 0RY
GB013 Recruiting
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: May 14, 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:
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Salivary plasminogen activator alpha 1, Desmodus rotundus
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on October 01, 2014