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

Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial

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.

Study Overview

• Status: Unknown
• Conditions: Stroke
• Intervention / Treatment: Drug: Anti-platelets and statin; Drug: alteplase; Procedure: intra arterial intervention

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Tareq Kass-Hout, MD; Phone Number: 716-887-5548; Email: kasshouttareq@gmail.com

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14209
      • Recruiting
      • Millard Fillmore Gates Circle Hospital
      • Contact: Annemarie Crumlish; Phone Number: 716-887-5548; Email: acrumlish@thejni.org
      • Principal Investigator: Elad Levy, MD
      • Sub-Investigator: Adnan H Siddiqui, MD,PhD
      • Sub-Investigator: Kenneth V Snyder, MD, PhD
      • Sub-Investigator: Robert N Sawyer, MD
      • Sub-Investigator: Marilou Ching, MD
      • Sub-Investigator: David Janicke, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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 orPlavix 75 mg PO daily orAggrenox 225mg PO twice daily; Anti-inflammatory therapy:Lipitor 80 mg PO daily orCrestor 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS) 90 days post treatment	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Institute of Health Stroke Scale (NIHSS)	National Institute of Health Stroke Scale (NIHSS) 24 hours post treatment.	24 hour
National Institute of Health Stroke Scale (NIHSS)	National Institute of Health Stroke Scale (NIHSS) at discharge (3-29 days)	3-29 day
Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS) at 30 days post treatment	30 post treatment
Thrombolysis In Myocardial Infarction (TIMI) Flow	Thrombolysis In Myocardial Infarction (TIMI) flow pre and post the intervention as an indicator of revascularization rate	Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure
Thomboylsis in Cerebral Ischemia (TICI) flow	Thomboylsis in Cerebral Ischemia (TICI) flow pre and post intervention as an indicator of revascularization rate	Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure
symptomatic intracranial Hemorrhage (ICH)	Incidence of symptomatic symptomatic intracranial Hemorrhage (ICH) within 72 hours of intervention defined by ECASSIII as 4 points worsening in NIHSS	72 hours
National Institute of Health Stroke Scale (NIHSS)	at 30 Day visit National Institute of Health Stroke Scale (NIHSS) will be assessed	30 Days

Collaborators and Investigators

• Sponsor: Jacobs Neurological Institute
• Collaborators: Genentech, Inc.; University at Buffalo Neurosurgery
• Investigators: Study Director: Elad I Levy, MD, University at Buffalo Neurosurgery; Principal Investigator: Tareq Kass-Hout, MD, Jacobs Neurological Institute

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): February 1, 2014

Study Registration Dates

• First Submitted: October 7, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (ESTIMATE): October 20, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 30, 2012
• Last Update Submitted That Met QC Criteria: March 29, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator
• Other Study ID Numbers: NEU 3200411A