Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-3)

September 17, 2015 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 3-9 hours from onset of stroke symptoms.

Study Overview

Status

Completed

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 3-9 hours after onset of stroke symptoms.

Study Type

Interventional

Enrollment (Actual)

492

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

  • Australia
      • Clayton, Australia, 3168
        • AU006
      • Gosford, Australia, 2250
        • AU004
      • Melbourne, Australia
        • AU001
      • Melbourne, Australia
        • AU002
      • New Castle, Australia
        • AU003
      • Perth, Australia, 6000
        • AU009
  • Austria
      • Graz, Austria, 8036
        • AT003
      • Innsbruck, Austria, 6020
        • AT004
      • Linz, Austria, 4020
        • AT002
      • Linz, Austria, 4021
        • AT001
      • Vienna, Austria, 1090
        • AT005
  • Estonia
      • Tallinn, Estonia, 10138
        • EE002
      • Tallinn, Estonia, 10617
        • EE004
      • Tallinn, Estonia, 13419
        • EE003
      • Tartu, Estonia, 51014
        • EE001
  • France
      • Besancon, France, 25000
        • FR004
      • Bordeaux, France, 33076
        • FR013
      • Bourg-en-Bresse, France, 1012
        • FR003
      • Caen, France, 14033
        • FR015
      • Lille, France, 59037
        • FR014
      • Limoges, France, 87042
        • FR012
      • Montpellier, France, 34295
        • FR008
      • Nice, France, 6000
        • FR010
      • Paris, France, 75010
        • FR001
      • Paris, France, 75014
        • FR009
      • Perpignan, France, 66046
        • FR007
      • Toulouse, France, 31059
        • FR016
  • Germany
      • Berlin, Germany, 12200
        • DE002
      • Dresden, Germany, 1307
        • DE001
      • Erlangen, Germany, 91054
        • DE011
      • Freiburg, Germany, 79104
        • DE005
      • Hamburg, Germany, 20246
        • DE018
      • Hannover, Germany, 30625
        • DE020
      • Jena, Germany, 7747
        • DE019
      • Leipzig, Germany, 4103
        • DE003
      • Lübeck, Germany
        • DE022
      • Neuruppin, Germany, 16816
        • DE021
      • Rostock, Germany, 18147
        • DE025
      • Schweinfurt, Germany, 97422
        • DE012
      • Wurzburg, Germany, 97080
        • DE016
  • Hong Kong
      • Hong Kong, Hong Kong
        • HK001
      • Hong Kong, Hong Kong
        • HK002
  • India
      • Chandigarh, India, 160012
        • IN004
      • Guntur, India, 522001
        • IN009
      • Hyderabad, India, 500001
        • IN008
      • Hyderabad, India, 500082
        • IN003
      • Ludhiana, India, 141008
        • IN007
      • Pune, India, 411001
        • IN001
  • Korea, Republic of
      • Ansan-Si, Korea, Republic of, 425 707
        • KR013
      • Anyang City, Korea, Republic of, 431 070
        • KR003
      • Busan, Korea, Republic of, 602-715
        • KR006
      • Daegu, Korea, Republic of
        • KR011
      • In Cheon, Korea, Republic of, 400-711
        • KR002
      • Kwangju, Korea, Republic of, 501757
        • KR010
      • Seongnam, Korea, Republic of, 463-707
        • KR008
      • Seoul, Korea, Republic of, 120-752
        • KR004
      • Seoul, Korea, Republic of, 137-710
        • KR001
      • Seoul, Korea, Republic of, 139711
        • KR012
      • Seoul, Korea, Republic of, 156707
        • KR009
      • Seoul, Korea, Republic of
        • KR005
      • Wonju-si, Korea, Republic of, 220-701
        • KR007
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • NL001
      • Groningen, Netherlands, 9713 GZ
        • NL002
  • Philippines
      • Manila, Philippines
        • PH003
      • Pasig City, Philippines
        • PH001
      • Quezon City, Philippines
        • PH002
  • Poland
      • Gdansk, Poland, 80952
        • PL004
      • Lublin, Poland, 29950
        • PL005
      • Sandomierz, Poland, 27600
        • PL006
      • Warszawa, Poland, 02-957
        • PL001
      • Warszawa, Poland, 02-957
        • PL002
  • Singapore
      • Singapore, Singapore, 169608
        • SG002
      • Singapore, Singapore
        • SG001
  • Spain
      • Albacete, Spain, 2006
        • ES010
      • Alcazar de San Juan, Spain, 13600
        • ES012
      • Barcelona, Spain, 8907
        • ES007
      • Barcelona, Spain, 8916
        • ES003
      • Bilbao, Spain, 48013
        • ES014
      • Girona, Spain, 17007
        • ES004
      • Lugo, Spain, 27003
        • ES013
      • Madrid, Spain, 28040
        • ES005
      • Madrid, Spain, 28034
        • ES011
      • Madrid, Spain, 75010
        • ES008
      • Valladolid, Spain, 47005
        • ES006
  • Switzerland
      • Lausanne, Switzerland, 1011
        • CH001
  • Taiwan
      • Kaohsiung, Taiwan, 807
        • TW003
      • Kaohsiung, Taiwan, 833
        • TW001
      • Taichung, Taiwan, 40447
        • TW006
      • Tainan, Taiwan, 704
        • TW005
      • Tainan, Taiwan, 710
        • TW008
      • Taipei, Taiwan, 100
        • TW009
      • Taipei, Taiwan, 10449
        • TW007
      • Taipei, Taiwan
        • TW002
      • Taoyuan, Taiwan, 333
        • TW004
  • Thailand
      • Bangkok, Thailand, 10330
        • TH003
      • Bangkok, Thailand, 10400
        • TH002
      • Bangkok, Thailand, 10400
        • TH006
      • Bangkok, Thailand, 10700
        • TH004
      • Chiang Mai, Thailand, 50200
        • TH005
      • Pathumthani, Thailand, 12120
        • TH001
  • Vietnam
      • Hanoi, Vietnam
        • VN002
      • Ho Chi Minh City, Vietnam
        • VN001

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 3-9 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

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 - 2 minutes on 1st day
Experimental: Desmoteplase
Drug: Desmoteplase
90 μg/kg bodyweight, IV, single bolus over 1 - 2 minutes on 1st day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Modified Rankin Scale Score
Time Frame: 90 days
90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
National Institutes of Health Stroke Scale (NIHSS) Score
Time Frame: 90 days
90 days

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

December 1, 2008

Primary Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 13, 2008

First Submitted That Met QC Criteria

November 13, 2008

First Posted (Estimate)

November 14, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2015

Last Update Submitted That Met QC Criteria

September 17, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12402A
  • 2008-000622-40 (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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