Status:
COMPLETED
Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)
Lead Sponsor:
PAION Deutschland GmbH
Conditions:
Stroke
Eligibility:
All Genders
18-85 years
Phase:
PHASE1
PHASE2
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 bot...
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. Altep...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2004
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT00638248
Start Date
March 1 2003
End Date
October 1 2004
Last Update
March 19 2008
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