Clinical trial NCT01455935: Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention
Official title: Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stroke
Lead sponsor: Jacobs Neurological Institute
Sponsor class: OTHER
Collaborators: name: University at Buffalo Neurosurgery
name: Genentech, Inc.
First posted: 2011-10-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to study the safety and the effectiveness of using CT Perfusion studies as an indicator to treat stroke patients with unknown time of onset.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria: To be eligible for entry into this study, candidates must meet all of the following eligibility criteria at the time of Emergency Department presentation:

1. Age: 18-80 years old
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:

Exclusion Criteria: Potential study patients will be excluded from study entry if any of the following exclusion criteria exist at the time of screening:

1. Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT
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

Primary outcomes:
measure: Modified Rankin Scale (mRS)
timeFrame: 90 days
Secondary outcomes:
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: 24 hour
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: 3-29 day
measure: Modified Rankin Scale (mRS)
timeFrame: 30 post treatment
measure: Thrombolysis In Myocardial Infarction (TIMI) Flow
timeFrame: Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure
measure: Thomboylsis in Cerebral Ischemia (TICI) flow
timeFrame: Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure
measure: symptomatic intracranial Hemorrhage (ICH)
timeFrame: 72 hours
measure: National Institute of Health Stroke Scale (NIHSS)
timeFrame: 30 Days
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Millard Fillmore Gates Circle Hospital
state: New York
Study officials:
affiliation: University at Buffalo Neurosurgery
name: Elad I Levy, MD
role: STUDY_DIRECTOR
affiliation: Jacobs Neurological Institute
name: Tareq Kass-Hout, MD
role: PRINCIPAL_INVESTIGATOR
References: