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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT00790920
First received: November 13, 2008
Last updated: March 14, 2014
Last verified: March 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 3-9 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

Resource links provided by NLM:


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: 479
Study Start Date: December 2008
Primary Completion Date: February 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 - 2 minutes on 1st day
Placebo Comparator: Placebo Drug: Placebo
IV, single bolus over 1 - 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 3-9 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 3-9 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
  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: NCT00790920

  Hide Study Locations
Locations
Australia
AU006
Clayton, Australia, 3168
AU004
Gosford, Australia, 2250
AU002
Melbourne, Australia
AU001
Melbourne, Australia
AU003
New Castle, Australia
AU009
Perth, Australia, 6000
Austria
AT003
Graz, Austria, 8036
AT004
Innsbruck, Austria, 6020
AT001
Linz, Austria, 4021
AT002
Linz, Austria, 4020
AT005
Vienna, Austria, 1090
Estonia
EE002
Tallinn, Estonia, 10138
EE003
Tallinn, Estonia, 13419
EE004
Tallinn, Estonia, 10617
EE001
Tartu, Estonia, 51014
France
FR004
Besancon, France, 25000
FR013
Bordeaux, France, 33076
FR003
Bourg-en-Bresse, France, 1012
FR015
Caen, France, 14033
FR014
Lille, France, 59037
FR012
Limoges, France, 87042
FR008
Montpellier, France, 34295
FR010
Nice, France, 6000
FR001
Paris, France, 75010
FR009
Paris, France, 75014
FR007
Perpignan, France, 66046
FR016
Toulouse, France, 31059
Germany
DE002
Berlin, Germany, 12200
DE001
Dresden, Germany, 1307
DE011
Erlangen, Germany, 91054
DE005
Freiburg, Germany, 79104
DE018
Hamburg, Germany, 20246
DE020
Hannover, Germany, 30625
DE019
Jena, Germany, 7747
DE003
Leipzig, Germany, 4103
DE022
Lübeck, Germany
DE021
Neuruppin, Germany, 16816
DE025
Rostock, Germany, 18147
DE012
Schweinfurt, Germany, 97422
DE016
Wurzburg, Germany, 97080
Hong Kong
HK001
Hong Kong, Hong Kong
HK002
Hong Kong, Hong Kong
India
IN004
Chandigarh, India, 160012
IN009
Guntur, India, 522001
IN003
Hyderabad, India, 500082
IN008
Hyderabad, India, 500001
IN007
Ludhiana, India, 141008
IN001
Pune, India, 411001
Korea, Republic of
KR013
Ansan-Si, Korea, Republic of, 425 707
KR003
Anyang City, Korea, Republic of, 431 070
KR006
Busan, Korea, Republic of, 602-715
KR011
Daegu, Korea, Republic of
KR002
In Cheon, Korea, Republic of, 400-711
KR010
Kwangju, Korea, Republic of, 501757
KR008
Seongnam, Korea, Republic of, 463-707
KR004
Seoul, Korea, Republic of, 120-752
KR001
Seoul, Korea, Republic of, 137-710
KR005
Seoul, Korea, Republic of
KR009
Seoul, Korea, Republic of, 156707
KR012
Seoul, Korea, Republic of, 139711
KR007
Wonju-si, Korea, Republic of, 220-701
Netherlands
NL001
Breda, Netherlands, 4818 CK
NL002
Groningen, Netherlands, 9713 GZ
Philippines
PH003
Manila, Philippines
PH001
Pasig City, Philippines
PH002
Quezon City, Philippines
Poland
PL004
Gdansk, Poland, 80952
PL005
Lublin, Poland, 29950
PL006
Sandomierz, Poland, 27600
PL001
Warszawa, Poland, 02-957
PL002
Warszawa, Poland, 02-957
Singapore
SG002
Singapore, Singapore, 169608
SG001
Singapore, Singapore
Spain
ES010
Albacete, Spain, 2006
ES012
Alcazar de San Juan, Spain, 13600
ES003
Barcelona, Spain, 8916
ES007
Barcelona, Spain, 8907
ES014
Bilbao, Spain, 48013
ES004
Girona, Spain, 17007
ES013
Lugo, Spain, 27003
ES005
Madrid, Spain, 28040
ES008
Madrid, Spain, 75010
ES011
Madrid, Spain, 28034
ES006
Valladolid, Spain, 47005
Switzerland
CH001
Lausanne, Switzerland, 1011
Taiwan
TW001
Kaohsiung, Taiwan, 833
TW003
Kaohsiung, Taiwan, 807
TW006
Taichung, Taiwan, 40447
TW005
Tainan, Taiwan, 704
TW008
Tainan, Taiwan, 710
TW002
Taipei, Taiwan
TW007
Taipei, Taiwan, 10449
TW009
Taipei, Taiwan, 100
TW004
Taoyuan, Taiwan, 333
Thailand
TH003
Bangkok, Thailand, 10330
TH004
Bangkok, Thailand, 10700
TH002
Bangkok, Thailand, 10400
TH006
Bangkok, Thailand, 10400
TH005
Chiang Mai, Thailand, 50200
TH001
Pathumthani, Thailand, 12120
Vietnam
VN002
Hanoi, Vietnam
VN001
Ho Chi Minh City, Vietnam
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: NCT00790920     History of Changes
Other Study ID Numbers: 12402A, 2008-000622-40
Study First Received: November 13, 2008
Last Updated: March 14, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Hong Kong: Department of Health
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Korea: Food and Drug Administration
Netherlands: Ministry of Health, Welfare and Sport
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic
Taiwan: National Bureau of Controlled Drugs
Thailand: Food and Drug Administration
Vietnam: Ministry of Health

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

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
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 August 21, 2014