Desmoteplase in Acute Ischemic Stroke (DIAS) - Full Text View

Sponsored by:	PAION Deutschland GmbH
Information provided by:	PAION Deutschland GmbH
ClinicalTrials.gov Identifier:	NCT00638781

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

Drug Information available for: Desmoteplase

U.S. FDA Resources

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
1: Active Comparator Desmoteplase 62.5 µg/kg BW i.v. bolus	Drug: Desmoteplase Desmoteplase 62.5 µg/kg BW
2: Active Comparator Desmoteplase 90 µg/kg BW i.v. bolus	Drug: Desmoteplase Desmoteplase 90 µg/kg BW
3: Active Comparator Desmoteplase 125 µg/kg BW i.v. bolus	Drug: Desmoteplase Desmoteplase 125 µg/kg BW
4: Placebo Comparator 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

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:

Related Info This link exits the ClinicalTrials.gov site

PAION Deutschland GmbH This link exits the ClinicalTrials.gov site

Publications:

Hacke W, Albers G, Al-Rawi Y, Bogousslavsky J, Davalos A, Eliasziw M, Fischer M, Furlan A, Kaste M, Lees KR, Soehngen M, Warach S; DIAS Study Group. The Desmoteplase in Acute Ischemic Stroke Trial (DIAS): a phase II MRI-based 9-hour window acute stroke thrombolysis trial with intravenous desmoteplase. Stroke. 2005 Jan;36(1):66-73. Epub 2004 Nov 29.

Responsible Party:	PAION Deutschland GmbH ( Karin Wilhelm-Ogunbiyi, MD / Medical Director & Head of Clinical Development )
Study ID Numbers:	PN01-CLD-000001/01
Study First Received:	March 12, 2008
Last Updated:	March 12, 2008
ClinicalTrials.gov Identifier:	NCT00638781 History of Changes
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

Study placed in the following topic categories:

Cerebral Infarction
Stroke
Vascular Diseases
Central Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Agents
Ischemia
Brain Diseases

Cerebrovascular Disorders
Fibrin Modulating Agents
Brain Ischemia
Brain Infarction
Infarction
Salivary plasminogen activator alpha 1, Desmodus rotundus
Plasminogen

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Hematologic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Fibrinolytic Agents
Cardiovascular Agents

Brain Diseases
Cerebrovascular Disorders
Pharmacologic Actions
Fibrin Modulating Agents
Therapeutic Uses
Brain Ischemia
Cardiovascular Diseases
Brain Infarction
Salivary plasminogen activator alpha 1, Desmodus rotundus

ClinicalTrials.gov processed this record on September 10, 2009