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Trial record 5 of 6 for:    desmoteplase

Desmoteplase in Acute Ischemic Stroke (DIAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00638781
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : March 19, 2008
Information provided by:
PAION Deutschland GmbH

Brief Summary:
The DIAS study (Part 2) was performed to support the dose finding of desmoteplase treatment in subjects with acute ischemic stroke selected by perfusion/diffusion mismatch on MRI within a time window of 3 to 9 h after stroke-symptom onset. In addition, it assessed safety and tolerability of 3 doses of desmoteplase compared with placebo with special consideration of intracranial hemorrhage and major systemic bleedings.

Condition or disease Intervention/treatment Phase
Stroke Drug: Desmoteplase Drug: Placebo Phase 2

Detailed Description:
Acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability. The outcome can be improved by early treatment with thrombolysis. Alteplase (r-tPA) is the only approved thrombolytic drug in the indication of acute ischemic stroke. However, the use of alteplase is currently restricted by the need to administer it within 3 hours of symptom onset. As the risk of transforming a cerebral infarct into haemorrhage probably rises as the time elapsed increases, a thrombolytic drug that carries a lower risk of haemorrhage than alteplase may offer a wider time-to-treatment window and improve the safety profile.Desmoteplase (DSPA) with its high fibrin specificity, lack of neurotoxicity, potential neuroprotective effect, non-activation by ß-amyloid, and long terminal half-life may account for an improved safety and efficacy profile within the first 9 hours after onset of symptoms.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre, Multinational, Double-Blind, Placebo-Controlled, Randomised Phase II Trial of Desmoteplase (INN) in the Indication of Acute Ischaemic Stroke
Study Start Date : March 2001
Actual Primary Completion Date : October 2003
Actual Study Completion Date : October 2003

Arm Intervention/treatment
Active Comparator: 1
Desmoteplase 62.5 µg/kg BW i.v. bolus
Drug: Desmoteplase
Desmoteplase 62.5 µg/kg BW

Active Comparator: 2
Desmoteplase 90 µg/kg BW i.v. bolus
Drug: Desmoteplase
Desmoteplase 90 µg/kg BW

Active Comparator: 3
Desmoteplase 125 µg/kg BW i.v. bolus
Drug: Desmoteplase
Desmoteplase 125 µg/kg BW

Placebo Comparator: 4
Placebo i.v. bolus
Drug: Placebo

Primary Outcome Measures :
  1. National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS [ Time Frame: Day 90 ]
  2. Change in lesion volume [ Time Frame: Day 30 ]

Secondary Outcome Measures :
  1. Reperfusion after 4-8 h [ Time Frame: 8 h ]
  2. Safety and pharmacoeconomic outcomes [ Time Frame: Day 90 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • scoring 4 to 20 on the National Institute of Health Stroke Scale (NIHSS)
  • showing a perfusion-diffusion mismatch on MRI of 20 %
  • enrolment within a 3 h to 9 h time window after symptom onset.
  • 18-85 years of age

Exclusion Criteria:

  • Participation in any interventional trial in the previous 30 days.
  • Women in the childbearing age.
  • Any history of intracranial hemorrhage, subarachnoid hemorrhage, neoplasm, arteriovenous malformation or aneurysm.
  • Conditions that, according to the judgment of the investigator, might impose an additional risk to any individual stroke patient when receiving study medication (this applied to patients on platelet-function inhibitors as well).
  • MRI exclusion criteria: Evidence of ICH, Evidence of SAH, Signs of extensive early infarction on DWI assessed by evidence of involvement of >1/3 of the middle cerebral artery (MCA) territory. No perfusion deficit, Internal carotid artery (ICA) occlusion ipsilateral to stroke lesion without additional ipsilateral MCA, anterior cerebral artery (ACA) or posterior cerebral artery (PCA) occlusion. Any intracranial pathology that would interfere with the MRI assessment of acute ischemic stroke.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00638781

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Prof. Dr. Werner Hacke
Heidelberg, Germany
Sponsors and Collaborators
PAION Deutschland GmbH
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Study Chair: Werner Hacke, Prof. Dr. Head of Neurology Department, University of Heidelberg

Additional Information:
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Karin Wilhelm-Ogunbiyi, MD / Medical Director & Head of Clinical Development, PAION Deutschland GmbH Identifier: NCT00638781     History of Changes
Other Study ID Numbers: PN01-CLD-000001/01
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: March 19, 2008
Last Verified: March 2008
Keywords provided by PAION Deutschland GmbH:
Acute ischemic stroke
Additional relevant MeSH terms:
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Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Salivary plasminogen activator alpha 1, Desmodus rotundus
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action