Desmoteplase in Acute Ischemic Stroke (DIAS)

This study has been completed.
Sponsor:
Information provided by:
PAION Deutschland GmbH
ClinicalTrials.gov Identifier:
NCT00638781
First received: March 12, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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 Intervention Phase
Stroke
Drug: Desmoteplase
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by PAION Deutschland GmbH:

Primary Outcome Measures:
  • National Institutes of Health Stroke Scale (NIHSS), Barthel-Index & mRS [ Time Frame: Day 90 ] [ Designated as safety issue: No ]
  • Change in lesion volume [ Time Frame: Day 30 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reperfusion after 4-8 h [ Time Frame: 8 h ] [ Designated as safety issue: No ]
  • Safety and pharmacoeconomic outcomes [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

Enrollment: 104
Study Start Date: March 2001
Study Completion Date: October 2003
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00638781

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Karin Wilhelm-Ogunbiyi, MD / Medical Director & Head of Clinical Development, PAION Deutschland GmbH
ClinicalTrials.gov Identifier: NCT00638781     History of Changes
Other Study ID Numbers: PN01-CLD-000001/01
Study First Received: March 12, 2008
Last Updated: March 12, 2008
Health Authority: Australia: National Health and Medical Research Council
Austria: Agency for Health and Food Safety
Belgium: Ministry of Social Affairs, Public Health and the Environment
Finland: Ministry of Social Affairs and Health
France: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Norway: Norwegian Medicines Agency
Singapore: Health Sciences Authority
Spain: Spanish Agency of Medicines
Switzerland: Federal Office of Public Health
United Kingdom: Department of Health

Keywords provided by PAION Deutschland GmbH:
Acute ischemic stroke

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 28, 2014