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

• Sponsor: Jacobs Neurological Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01455935
• Collaborator: University at Buffalo Neurosurgery (Other), Genentech, Inc. (Industry)
• Enrollment: 90
• Location: 1
• Arms: 3
• Duration (Months): 27
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Drug: Anti-platelets and statin; Drug: alteplase; Procedure: intra arterial intervention	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial
• Study Start Date: Nov 1, 2011
• Anticipated Primary Completion Date: Dec 1, 2013
• Anticipated Study Completion Date: Feb 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Medical Therapy Current standard of care per the latest stroke guidelines Permissive Hypertension up to 220 Antipletelets therapy: ASA 81 mg PO daily or Plavix 75 mg PO daily or Aggrenox 225mg PO twice daily Anti-inflammatory therapy: Lipitor 80 mg PO daily or Crestor 20 mg PO daily	Drug: Anti-platelets and statin
Experimental: 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	Drug: 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
Experimental: Intra-Arterial Therapy -Choice of therapy per experienced Endovascular surgeon and includes: Intra arterial Activase (Maximum dose of 22 mg) MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes) PENUMBRA device (no standard time frame for how long the procedure takes)	Procedure: intra arterial intervention; Intra arterial Activase (Maximum dose of 22 mg) MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes) PENUMBRA device (no standard time frame for how long the procedure takes)

Outcome Measures

Primary Outcome Measures

1. Modified Rankin Scale (mRS) [90 days]

   Modified Rankin Scale (mRS) 90 days post treatment

Secondary Outcome Measures

1. National Institute of Health Stroke Scale (NIHSS) [24 hour]

   National Institute of Health Stroke Scale (NIHSS) 24 hours post treatment.

2. National Institute of Health Stroke Scale (NIHSS) [3-29 day]

   National Institute of Health Stroke Scale (NIHSS) at discharge (3-29 days)

3. Modified Rankin Scale (mRS) [30 post treatment]

   Modified Rankin Scale (mRS) at 30 days post treatment

4. Thrombolysis In Myocardial Infarction (TIMI) Flow [Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure]

   Thrombolysis In Myocardial Infarction (TIMI) flow pre and post the intervention as an indicator of revascularization rate

5. Thomboylsis in Cerebral Ischemia (TICI) flow [Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure]

   Thomboylsis in Cerebral Ischemia (TICI) flow pre and post intervention as an indicator of revascularization rate

6. symptomatic intracranial Hemorrhage (ICH) [72 hours]

   Incidence of symptomatic symptomatic intracranial Hemorrhage (ICH) within 72 hours of intervention defined by ECASSIII as 4 points worsening in NIHSS

7. National Institute of Health Stroke Scale (NIHSS) [30 Days]

   at 30 Day visit National Institute of Health Stroke Scale (NIHSS) will be assessed

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Millard Fillmore Gates Circle Hospital	Buffalo	New York	United States	14209

Sponsors and Collaborators

• Jacobs Neurological Institute
• University at Buffalo Neurosurgery
• Genentech, Inc.

Investigators

• Study Director: Elad I Levy, MD, University at Buffalo Neurosurgery
• Principal Investigator: Tareq Kass-Hout, MD, Jacobs Neurological Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tareq Kass-Hout, Chief Vascular/Neurology Resident in charge of stroke, Jacobs Neurological Institute
• ClinicalTrials.gov Identifier: NCT01455935
• Other Study ID Numbers: NEU 3200411A
• First Posted: Oct 20, 2011
• Last Update Posted: Mar 30, 2012
• Last Verified: Mar 1, 2012

• Additional relevant MeSH terms: Stroke; Tissue Plasminogen Activator

Study Results

No Results Posted as of Mar 30, 2012