Wake up Symptomatic Stroke - Benefit of Intravenous Clot Busters or Endovascular Intervention

• Status: Unknown status
• Trial end date: 2014-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jacobs Neurological Institute
• Collaborators: Genentech, Inc.; University at Buffalo Neurosurgery
• Treatments: Tissue Plasminogen Activator

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