Study for the Use of Alteplase in Patients Who Awaken With Stroke
NCT ID: NCT01150266
Last Updated: 2013-09-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2011-08-31
Brief Summary
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Detailed Description
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Many patients awaken with stroke and are excluded from this therapy, following current guidelines.
Patients who suffer from a stroke just before or after waking up may be candidates for thrombolysis and our study will use advanced neuroimaging to select those patients.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Alteplase
Alteplase 0.9mg/kg (maximum 90mg), 10% IV bolus over 1 minute and the remainder over one hour infusion in patients with ischemic stroke after awaking.
Alteplase (tPA)
0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.
Interventions
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Alteplase (tPA)
0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Stroke upon awakening
3. Measurable deficit by NIHSS
4. No deficit before sleep or last seen normal before to sleep
5. Head CT with no evidence of intracranial hemorrhage.
6. Able to receive IV t-PA treatment within 2.5 hrs after patient awoke with deficit.
7. Written informed consent signed and dated by the patient (or patient's authorized representative)
8. Core lesion: ASPECTS ≥7 on MRI-DWI, CTP-CBV or CTA source imaging.
9. Mismatch of at least 20% measured by CT CVB/MMT or DWI/TTP
Exclusion Criteria
2. Major surgery or serious trauma within 14 days
3. History of intracranial hemorrhage
4. Systolic blood pressure above 185 mm Hg or diastolic blood pressure above 110 mm Hg that is not controlled after aggressive measures.
5. Rapidly improving or minor symptoms
6. Symptoms suggestive of subarachnoid hemorrhage.
7. Gastrointestinal hemorrhage or urinary tract hemorrhage within the previous 21 days.
8. Arterial puncture at a non-compressible site within the previous 7 days
9. Seizure at the onset of stroke and considered the cause for the neurological symptom.
10. Patients who are taking anticoagulants or who had received heparin within the 48 hours preceding the onset of stroke and have an elevated partial-thromboplastin time, INR\>1.7 or platelet counts below 100,000/mm3
11. Finger sticks glucose below 50 mg/dl (2.7 mmol/ Lt) or above 400 mg per deciliter (22.2 mmol/Lt) and considered the cause for the neurological symptom.
12. Active internal bleeding
13. Pregnancy in women of child-bearing potential (must have pregnancy test, urine or blood, prior to therapy).
14. Lumbar puncture within 7 days.
15. Known co-morbid conditions likely to complicate therapy or interfere with patient assessment, such us: heart failure stage 4, severe dementia, end-stage AIDS, pericarditis, cirrhosis or known cancer.
16. Unable to obtain CTA or perfusion brain studies (PWI or CTP)
22 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Scripps Health
OTHER
University of California, San Diego
OTHER
Responsible Party
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Thomas M Hemmen
Director, UCSD Stroke Center
Locations
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University of California, San Diego
San Diego, California, United States
Countries
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Related Links
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UCSD Stroke Center
Other Identifiers
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AWOKE
Identifier Type: -
Identifier Source: org_study_id
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