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

This study is currently recruiting participants.
Verified April 2013 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: April 13, 2013
Last verified: April 2013
History of Changes
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856661

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

  Show 153 Study Locations
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: April 13, 2013
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
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
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 May 23, 2013