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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00638248 |
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Date of registration:
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12/03/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dose Escalation of Desmoteplase in Acute Ischemic Stroke (DEDAS)
DEDAS |
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Scientific title:
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International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Phase I/II Trial of Desmoteplase in the Indication of Acute Ischemic Stroke |
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Date of first enrolment:
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March 2003 |
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Target sample size:
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38 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00638248 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Contacts
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Name:
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Antony J. Furlan, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Neurology; the Cleveland Clinic Foundation |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Drug: Placebo
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Drug: Desmoteplase
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Primary Outcome(s)
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Reperfusion after 4-8 h
[Time Frame: 8 h]
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National Institutes of Health Stroke Scale (NIHSS), Barthel-Index, mRS
[Time Frame: Day 90]
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Infarct lesion volume after 30 days
[Time Frame: Day 30]
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Safety & pharmacokinetic outcomes
[Time Frame: Day 90]
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Secondary ID(s)
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PN01-CLD-000002/01
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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