Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS) (DEDAS)
Primary Purpose
Stroke
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Desmoteplase
Desmoteplase
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Acute ischemic stroke
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
Desmoteplase 90µg/kg BW
Desmoteplase 125 µg/kg BW
Placebo
Outcomes
Primary Outcome Measures
National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS
Reperfusion after 4-8 h
Infarct lesion volume after 30 days
Safety & pharmacokinetic outcomes
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00638248
Brief Title
Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)
Acronym
DEDAS
Official Title
International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase I/II Trial of Desmoteplase in the Indication of Acute Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
PAION Deutschland GmbH
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to explore trends in safety and efficacy, and to find the optimal dose for the subsequent phase III trial. The decision to initiate the phase III trial will depend on both safety (incidence of symptomatic intracranial hemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles. The safety (incidence of symptomatic intracranial haemorrhage) and efficacy (reperfusion measured by MRI and correlating with clinical outcome) profiles gained from this study were the basis of planning the phase III.
Detailed Description
Acute stroke is the third leading cause of mortality in developed countries and the major medical cause of disability in adults. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Acute ischemic stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Desmoteplase 90µg/kg BW
Arm Title
2
Arm Type
Active Comparator
Arm Description
Desmoteplase 125 µg/kg BW
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Desmoteplase
Intervention Description
Desmoteplase 90µg/kg BW i.v. bolus
Intervention Type
Drug
Intervention Name(s)
Desmoteplase
Intervention Description
Desmoteplase 125 µg/kg BW i.v. bolus
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo i.v. bolus
Primary Outcome Measure Information:
Title
National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS
Time Frame
Day 90
Title
Reperfusion after 4-8 h
Time Frame
8 h
Title
Infarct lesion volume after 30 days
Time Frame
Day 30
Title
Safety & pharmacokinetic outcomes
Time Frame
Day 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antony J. Furlan, MD
Organizational Affiliation
Department of Neurology; the Cleveland Clinic Foundation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
16574922
Citation
Furlan AJ, Eyding D, Albers GW, Al-Rawi Y, Lees KR, Rowley HA, Sachara C, Soehngen M, Warach S, Hacke W; DEDAS Investigators. Dose Escalation of Desmoteplase for Acute Ischemic Stroke (DEDAS): evidence of safety and efficacy 3 to 9 hours after stroke onset. Stroke. 2006 May;37(5):1227-31. doi: 10.1161/01.STR.0000217403.66996.6d. Epub 2006 Mar 30.
Results Reference
result
PubMed Identifier
22738918
Citation
Warach S, Al-Rawi Y, Furlan AJ, Fiebach JB, Wintermark M, Lindsten A, Smyej J, Bharucha DB, Pedraza S, Rowley HA. Refinement of the magnetic resonance diffusion-perfusion mismatch concept for thrombolytic patient selection: insights from the desmoteplase in acute stroke trials. Stroke. 2012 Sep;43(9):2313-8. doi: 10.1161/STROKEAHA.111.642348. Epub 2012 Jun 26.
Results Reference
derived
PubMed Identifier
22474060
Citation
Fiebach JB, Al-Rawi Y, Wintermark M, Furlan AJ, Rowley HA, Lindsten A, Smyej J, Eng P, Warach S, Pedraza S. Vascular occlusion enables selecting acute ischemic stroke patients for treatment with desmoteplase. Stroke. 2012 Jun;43(6):1561-6. doi: 10.1161/STROKEAHA.111.642322. Epub 2012 Apr 3.
Results Reference
derived
Links:
URL
http://www.paion.de
Description
PAION Deutschland GmbH
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Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)
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