Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention
NCT ID: NCT01455935
Last Updated: 2012-03-30
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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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2011-11-30
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Medical Therapy
Current standard of care per the latest stroke guidelines
* Permissive Hypertension up to 220
* Antipletelets therapy:
1. ASA 81 mg PO daily or
2. Plavix 75 mg PO daily or
3. Aggrenox 225mg PO twice daily
* Anti-inflammatory therapy:
1. Lipitor 80 mg PO daily or
2. Crestor 20 mg PO daily
Anti-platelets and statin
Intravenous Thrombolysis
Full dose Intravenous thrombolysis
* 0.9 mg/kg
* Maximum dose is 90 mg
* 10% of the dose will be given over one minute
* 90% of the dose will be infused over 1 hour
* Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications
* Neuro checks every 5 minutes during the infusion
* Neuro checks every hour after the infusion for 24 hours
alteplase
Full dose Intravenous thrombolysis
* 0.9 mg/kg
* Maximum dose is 90 mg
* 10% of the dose will be given over one minute
* 90% of the dose will be infused over 1 hour
* Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications
* Neuro checks every 5 minutes during the infusion
* Neuro checks every hour after the infusion for 24 hours
Intra-Arterial Therapy
-Choice of therapy per experienced Endovascular surgeon and includes:
1. Intra arterial Activase (Maximum dose of 22 mg)
2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)
3. PENUMBRA device (no standard time frame for how long the procedure takes)
intra arterial intervention
1. Intra arterial Activase (Maximum dose of 22 mg)
2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)
3. PENUMBRA device (no standard time frame for how long the procedure takes)
Interventions
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Anti-platelets and statin
alteplase
Full dose Intravenous thrombolysis
* 0.9 mg/kg
* Maximum dose is 90 mg
* 10% of the dose will be given over one minute
* 90% of the dose will be infused over 1 hour
* Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications
* Neuro checks every 5 minutes during the infusion
* Neuro checks every hour after the infusion for 24 hours
intra arterial intervention
1. Intra arterial Activase (Maximum dose of 22 mg)
2. MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)
3. PENUMBRA device (no standard time frame for how long the procedure takes)
Eligibility Criteria
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Inclusion Criteria
2. Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen normal)
3. National Institute of Health Stroke Scale (NIHSS) 8-22
4. Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above
5. Alberta Stroke Program Early Computed Tomography (CT) Score (ASPECTS 7 or more)
6. Signed informed consent
Exclusion Criteria
2. Historical Modified Rankin Scale (mRS) of ≥2
3. National Institute of Health Stroke Scale (NIHSS)\<8 at the time of treatment
4. Positive pregnancy test in women at age of childbearing
5. Intracranial or intraspinal surgery within 3 months
6. Stroke or serious head injury within 3 months
7. History of intracranial hemorrhage
8. Uncontrolled hypertension at time of treatment (eg, \>185 mm Hg systolic or \>110 mm Hg diastolic)
9. Seizure at the onset of stroke
10. Active internal bleeding
11. Intracranial neoplasm
12. Arteriovenous malformation or aneurysm
13. Clinical presentation suggesting post-MI pericarditis
14. Known bleeding diathesis including but not limited to current use of oral anticoagulants producing an Internation normalized ratio (INR) \>1.7
15. Internation normalized ratio (INR) \>1.7
16. Administration of heparin within 48 hours preceding the onset of stroke with an elevated activated Partial Thromboplastin Time(aPTT) at presentation
17. Platelet count \<100,000/mm
18. Major surgery within 2 weeks
19. GastroIntestinal (GI) or urinary tract hemorrhage within 3 weeks
20. Aggressive treatment required to lower blood pressure
21. Glucose level \<50 or \>400 mg/dL
22. Arterial puncture at a noncompressible site or lumbar puncture within 1 week
18 Years
80 Years
ALL
No
Sponsors
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University at Buffalo Neurosurgery
OTHER
Genentech, Inc.
INDUSTRY
Jacobs Neurological Institute
OTHER
Responsible Party
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Tareq Kass-Hout
Chief Vascular/Neurology Resident in charge of stroke
Principal Investigators
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Elad I Levy, MD
Role: STUDY_DIRECTOR
University at Buffalo Neurosurgery
Tareq Kass-Hout, MD
Role: PRINCIPAL_INVESTIGATOR
Jacobs Neurological Institute
Locations
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Millard Fillmore Gates Circle Hospital
Buffalo, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Annemarie Crumlish
Role: primary
Other Identifiers
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NEU 3200411A
Identifier Type: -
Identifier Source: org_study_id