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

February 8, 2017 updated by: H. Lundbeck A/S

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

270

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • BE008
      • Hasselt, Belgium, 3500
        • BE004
      • Roeselare, Belgium, 8800
        • BE005
      • Wilrijk, Belgium, 2610
        • BE006
  • Brazil
      • Campinas, Brazil, 13083-970
        • BR012
      • Porto Alegre, Brazil, 90020-090
        • BR004
      • Porto Alegre, Brazil, 90035-003
        • BR008
      • Porto Alegre, Brazil, 90110-270
        • BR007
      • Rio de Janeiro, Brazil, 20941-150
        • BR009
      • Rio de Janeiro, Brazil, 22280-000
        • BR011
      • Salvador, Brazil, 40140-110
        • BR006
  • Canada
      • Edmonton, Canada, T6L 5X8
        • CA004
      • Halifax, Canada, B3H 3A7
        • CA006
      • Mississauga, Canada, L5B 1B8
        • CA008
      • Ottawa, Canada, K1Y 4E9
        • CA007
      • Toronto, Canada, M4N 3M5
        • CA012
      • Toronto, Canada, M5T 2S8
        • CA002
      • Victoria, Canada, V8R 1J8
        • CA005
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • CA001
  • Chile
      • Santiago, Chile
        • CL002
      • Santiago, Chile
        • CL003
      • Santiago, Chile
        • CL004
      • Santiago, Chile
        • CL006
      • Valparaiso, Chile
        • CL005
  • Denmark
      • Aalborg, Denmark, 9000
        • DK002
      • Aarhus, Denmark, 8000
        • DK001
      • Copenhagen NV, Denmark, 2400
        • DK004
      • Glostrup, Denmark, 2600
        • DK003
  • Finland
      • Helsinki, Finland, 29
        • FI001
      • Tampere, Finland, 33520
        • FI002
      • Turku, Finland, 20520
        • FI003
  • Ireland
      • Dublin, Ireland, 8
        • IE001
  • Italy
      • Ancona, Italy, 60020
        • IT010
      • Brescia, Italy, 25123
        • IT008
      • Firenze, Italy, 50019
        • IT003
      • Imperia, Italy, 18100
        • IT004
      • Milano, Italy, 20132
        • IT002
      • Milano, Italy, 20153
        • IT006
      • Milano, Italy, 20162
        • IT009
      • Modena, Italy, 41100
        • IT012
      • Rome, Italy, 161
        • IT001
      • Rome, Italy, 189
        • IT005
      • Rozzano, Italy, 20089
        • IT007
      • Verona, Italy, 37126
        • IT011
  • Mexico
      • D.f., Mexico, 14269
        • MX002
      • Mexico City, Mexico, 14000
        • MX003
      • Mexico City, Mexico, 14050
        • MX004
      • Monterrey Nuevo Leon, Mexico
        • MX005
  • Norway
      • Bergen, Norway, 2021
        • NO003
      • Oslo, Norway, 0027
        • NO001
      • Trondheim, Norway, 7006
        • NO002
  • South Africa
      • Cape Town, South Africa, 7130
        • ZA003
      • Cape Town, South Africa, 7405
        • ZA002
      • Cape Town, South Africa, 7800
        • ZA001
  • Sweden
      • Lund, Sweden, 221 85
        • SE002
      • Malmø, Sweden, 205 02
        • SE001
  • United Kingdom
      • Belfast, United Kingdom, BT12 6BJ
        • GB012
      • Christchurch, United Kingdom, BH23 2JX
        • GB004
      • Dundee, United Kingdom, DD1 9SY
        • GB010
      • Exeter, United Kingdom, EX2 5DW
        • GB002
      • Glasgow, United Kingdom, G11 6NT
        • GB009
      • Glasgow, United Kingdom, G51 4TF
        • GB007
      • Liverpool, United Kingdom, L7 8XP
        • GB011
      • London, United Kingdom, SE5 8AF
        • GB006
      • London, United Kingdom, SW17 0RE
        • GB003
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • GB001
      • Nottingham, United Kingdom, NG5 1PB
        • GB016
      • Sheffield, United Kingdom, S10 2JF
        • GB014
      • Stoke on Trent, United Kingdom, ST4 6QG
        • GB005
      • Westcliff-on-Sea, United Kingdom, SS0 0RY
        • GB015
      • Wolverhampton, United Kingdom, WV10 0QP
        • GB013
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • US053
    • California
      • Castro Valley, California, United States, 94546
        • US081
      • La Jolla, California, United States, 92037
        • US089
      • Loma Linda, California, United States, 92354
        • US043
      • Los Angeles, California, United States, 90024-1777
        • US008
      • Palo Alto, California, United States, 94304
        • US020
      • Pasadena, California, United States, 91105
        • US050
      • Santa Barbara, California, United States, 93105
        • US098
      • Thousand Oaks, California, United States, 91360
        • US051
    • Colorado
      • Englewood, Colorado, United States, 80113
        • US068
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • US063
      • New Haven, Connecticut, United States, 06510
        • US104
    • Florida
      • Pensacola, Florida, United States, 32504
        • US049
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • US109
      • Augusta, Georgia, United States, 30912
        • US042
      • Columbus, Georgia, United States, 31902
        • US052
      • Decatur, Georgia, United States, 30033
        • US080
      • Lawrenceville, Georgia, United States, 30045
        • US040
      • Macon, Georgia, United States, 31201
        • US067
      • Savannah, Georgia, United States, 31405
        • US085
      • Savannah, Georgia, United States, 31419
        • US086
    • Illinois
      • Chicago, Illinois, United States, 60611
        • US093
      • Chicago, Illinois, United States, 60612
        • US101
      • Chicago, Illinois, United States, 60622
        • US044
      • Evanston, Illinois, United States, 60201
        • US074
      • Glenview, Illinois, United States, 60026
        • US073
      • Maywood, Illinois, United States, 60153
        • US091
      • Oak Lawn, Illinois, United States, 60453
        • US088
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • US016
    • Iowa
      • Des Moines, Iowa, United States, 50314-2611
        • US072
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • US061
      • New Orleans, Louisiana, United States, 70121
        • US108
      • Shreveport, Louisiana, United States, 71130-3932
        • US064
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • US014
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • US039
      • Boston, Massachusetts, United States, 02118
        • US003
      • Worcester, Massachusetts, United States, 01605
        • US017
    • Michigan
      • Detroit, Michigan, United States, 48201
        • US066
      • Detroit, Michigan, United States, 48202
        • US096
      • Detroit, Michigan, United States, 48236
        • US083
      • Grand Blanc, Michigan, United States, 48439
        • US060
      • Grand Rapids, Michigan, United States, 49503
        • US078
      • Kalamazoo, Michigan, United States, 49007
        • US103
      • Petoskey, Michigan, United States, 49770
        • US056
      • Royal Oak, Michigan, United States, 48073
        • US113
      • Southfield, Michigan, United States, 48075
        • US076
      • Southfield, Michigan, United States, 48075
        • US082
      • Troy, Michigan, United States, 48085
        • US079
    • Mississippi
      • Gulfport, Mississippi, United States, 39502
        • US059
    • Missouri
      • Springfield, Missouri, United States, 65807
        • US048
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • US077
    • New Jersey
      • Edison, New Jersey, United States, 08818
        • US055
      • Neptune, New Jersey, United States, 07753
        • US115
      • Ridgewood, New Jersey, United States, 07450
        • US100
    • New York
      • Albany, New York, United States, 12208
        • US075
      • Brooklyn, New York, United States, 11220
        • US102
      • Buffalo, New York, United States, 14203
        • US012
      • Stony Brook, New York, United States, 11794-8121
        • US026
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • US037
      • Winston-Salem, North Carolina, United States, 27157
        • US069
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • US038
      • Columbus, Ohio, United States, 43210
        • US001
      • Columbus, Ohio, United States, 43214
        • US062
      • Toledo, Ohio, United States, 43614
        • US046
    • Oregon
      • Springfield, Oregon, United States, 97477
        • US095
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • US070
      • Philadelphia, Pennsylvania, United States, 19141
        • US023
      • Pittsburg, Pennsylvania, United States, 15212
        • US099
      • Pittsburg, Pennsylvania, United States, 15213
        • US084
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • US092
      • Warwick, Rhode Island, United States, 02886
        • US087
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • US057
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • US019
      • Nashville, Tennessee, United States, 37205
        • US058
    • Texas
      • Houston, Texas, United States, 77030
        • US021
      • Houston, Texas, United States, 77030
        • US031
      • Houston, Texas, United States, 77030
        • US112
    • Virginia
      • Richmond, Virginia, United States, 23298
        • US047
      • Winchester, Virginia, United States, 22601
        • US006
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • US011
      • Milwaukee, Wisconsin, United States, 53226
        • US097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
IV, single bolus over 1 to 2 minutes on 1st day
Experimental: Desmoteplase
Drug: Desmoteplase
90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin Scale Score (mRS) (Percentage of Participants With mRS Scores 0-2)
Time Frame: 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
Day 90

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Institutes of Health Stroke Scale (NIHSS) Score. (Percentage of Participants With NIHSS Scores <=1 or NIHSS Decrease >=8)
Time Frame: 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.
90 days
Composite of mRS & NIHSS Response (Percentage of Participants With mRS Scores 0-2 and (NIHSS <= 1 or NIHSS Decrease >= 8)
Time Frame: Day 90
Please see outcomes measure one and two for detailed description of the scales
Day 90
Modified Ranking Scale Score (Using the Ordinal Scale)
Time Frame: Day 90
Please see outcomes measure one for detailed description of the mRS scale
Day 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lundbeck A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 5, 2009

First Submitted That Met QC Criteria

March 5, 2009

First Posted (Estimate)

March 6, 2009

Study Record Updates

Last Update Posted (Actual)

March 16, 2017

Last Update Submitted That Met QC Criteria

February 8, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12649A
  • 2008-005539-14 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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