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

This study is currently recruiting participants.
Verified March 2012 by Jacobs Neurological Institute
Sponsor:
Collaborators:
University at Buffalo Neurosurgery
Genentech
Information provided by (Responsible Party):
Tareq Kass-Hout, Jacobs Neurological Institute
ClinicalTrials.gov Identifier:
NCT01455935
First received: October 7, 2011
Last updated: March 29, 2012
Last verified: March 2012
History of Changes
  Purpose

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 Intervention Phase
Stroke
 Drug: Anti-platelets and statin
Drug: alteplase
Procedure: intra arterial intervention
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial

Resource links provided by NLM:

Drug Information available for: Alteplase
U.S. FDA Resources

Further study details as provided by Jacobs Neurological Institute:

Primary Outcome Measures:
  • Modified Rankin Scale (mRS) [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Modified Rankin Scale (mRS) 90 days post treatment


Secondary Outcome Measures:
  • National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 24 hour ] [ Designated as safety issue: No ]
    National Institute of Health Stroke Scale (NIHSS) 24 hours post treatment.

  • National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 3-29 day ] [ Designated as safety issue: No ]
    National Institute of Health Stroke Scale (NIHSS) at discharge (3-29 days)

  • Modified Rankin Scale (mRS) [ Time Frame: 30 post treatment ] [ Designated as safety issue: No ]
    Modified Rankin Scale (mRS) at 30 days post treatment

  • Thrombolysis In Myocardial Infarction (TIMI) Flow [ Time Frame: Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure ] [ Designated as safety issue: No ]
    Thrombolysis In Myocardial Infarction (TIMI) flow pre and post the intervention as an indicator of revascularization rate

  • Thomboylsis in Cerebral Ischemia (TICI) flow [ Time Frame: Pre - will be no more than 1 hour prior to procedure and post will be no more then 1 hour after completion of procedure ] [ Designated as safety issue: No ]
    Thomboylsis in Cerebral Ischemia (TICI) flow pre and post intervention as an indicator of revascularization rate

  • symptomatic intracranial Hemorrhage (ICH) [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    Incidence of symptomatic symptomatic intracranial Hemorrhage (ICH) within 72 hours of intervention defined by ECASSIII as 4 points worsening in NIHSS

  • National Institute of Health Stroke Scale (NIHSS) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
    at 30 Day visit National Institute of Health Stroke Scale (NIHSS) will be assessed


Estimated Enrollment: 90
Study Start Date: November 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
 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:

  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)
 Procedure: 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455935

Contacts
Contact: Tareq Kass-Hout, MD 716-887-5548 kasshouttareq@gmail.com

Locations
United States, New York
Millard Fillmore Gates Circle Hospital Recruiting
Buffalo, New York, United States, 14209
Contact: Annemarie Crumlish     716-887-5548     acrumlish@thejni.org    
Principal Investigator: Tareq Kass-Hout, MD            
Principal Investigator: Elad Levy, MD            
Sub-Investigator: Adnan H Siddiqui, MD,PhD            
Sub-Investigator: Kenneth V Snyder, MD, PhD            
Sub-Investigator: L N Hopkins, MD            
Sub-Investigator: Robert N Sawyer, MD            
Sub-Investigator: Marilou Ching, MD            
Sub-Investigator: David Janicke, MD            
Sponsors and Collaborators
Jacobs Neurological Institute
University at Buffalo Neurosurgery
Genentech
Investigators
Study Director: Elad I Levy, MD University at Buffalo Neurosurgery
Principal Investigator: Tareq Kass-Hout, MD Jacobs Neurological Institute
  More Information

No publications provided

Responsible Party: Tareq Kass-Hout, Chief Vascular/Neurology Resident in charge of stroke, Jacobs Neurological Institute
ClinicalTrials.gov Identifier: NCT01455935     History of Changes
Other Study ID Numbers: NEU 3200411A
Study First Received: October 7, 2011
Last Updated: March 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
 Brain Ischemia
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Hematologic Agents

ClinicalTrials.gov processed this record on May 16, 2013