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

Primary Purpose

Stroke

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Anti-platelets and statin

alteplase

intra arterial intervention

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

Age: 18-80 years old
Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen normal)
National Institute of Health Stroke Scale (NIHSS) 8-22
Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above
Alberta Stroke Program Early Computed Tomography (CT) Score (ASPECTS 7 or more)
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:

Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT
Historical Modified Rankin Scale (mRS) of ≥2
National Institute of Health Stroke Scale (NIHSS)<8 at the time of treatment
Positive pregnancy test in women at age of childbearing
Intracranial or intraspinal surgery within 3 months
Stroke or serious head injury within 3 months
History of intracranial hemorrhage
Uncontrolled hypertension at time of treatment (eg, >185 mm Hg systolic or >110 mm Hg diastolic)
Seizure at the onset of stroke
Active internal bleeding
Intracranial neoplasm
Arteriovenous malformation or aneurysm
Clinical presentation suggesting post-MI pericarditis
Known bleeding diathesis including but not limited to current use of oral anticoagulants producing an Internation normalized ratio (INR) >1.7
Internation normalized ratio (INR) >1.7
Administration of heparin within 48 hours preceding the onset of stroke with an elevated activated Partial Thromboplastin Time(aPTT) at presentation
Platelet count <100,000/mm
Major surgery within 2 weeks
GastroIntestinal (GI) or urinary tract hemorrhage within 3 weeks
Aggressive treatment required to lower blood pressure
Glucose level <50 or >400 mg/dL
Arterial puncture at a noncompressible site or lumbar puncture within 1 week

Sites / Locations

Millard Fillmore Gates Circle HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

Medical Therapy

Intravenous Thrombolysis

Intra-Arterial Therapy

Arm Description

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

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

-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)

Outcomes

Primary Outcome Measures

Modified Rankin Scale (mRS)

Modified Rankin Scale (mRS) 90 days post treatment

Secondary Outcome Measures

National Institute of Health Stroke Scale (NIHSS)

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

National Institute of Health Stroke Scale (NIHSS)

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

Modified Rankin Scale (mRS)

Modified Rankin Scale (mRS) at 30 days 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

Thomboylsis in Cerebral Ischemia (TICI) flow

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

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

National Institute of Health Stroke Scale (NIHSS)

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

Full Information

NCT ID

NCT01455935

First Posted

October 7, 2011

Last Updated

March 29, 2012

Sponsor

Jacobs Neurological Institute

Collaborators

University at Buffalo Neurosurgery, Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01455935

Brief Title

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

Acronym

WASSABI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Unknown status

Study Start Date

November 2011 (undefined)

Primary Completion Date

December 2013 (Anticipated)

Study Completion Date

February 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jacobs Neurological Institute

Collaborators

University at Buffalo Neurosurgery, Genentech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Medical Therapy

Arm Type

Active Comparator

Arm Description

Arm Title

Intravenous Thrombolysis

Arm Type

Experimental

Arm Description

Arm Title

Intra-Arterial Therapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Anti-platelets and statin

Intervention Type

Drug

Intervention Name(s)

alteplase

Intervention Description

Intervention Type

Procedure

Intervention Name(s)

intra arterial intervention

Intervention Description

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)

Primary Outcome Measure Information:

Title

Modified Rankin Scale (mRS)

Description

Modified Rankin Scale (mRS) 90 days post treatment

Time Frame

90 days

Secondary Outcome Measure Information:

Title

National Institute of Health Stroke Scale (NIHSS)

Description

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

Time Frame

24 hour

Title

National Institute of Health Stroke Scale (NIHSS)

Description

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

Time Frame

3-29 day

Title

Modified Rankin Scale (mRS)

Description

Modified Rankin Scale (mRS) at 30 days post treatment

Time Frame

30 post treatment

Title

Thrombolysis In Myocardial Infarction (TIMI) Flow

Description

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

Time Frame

Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure

Title

Thomboylsis in Cerebral Ischemia (TICI) flow

Description

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

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

Title

symptomatic intracranial Hemorrhage (ICH)

Description

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

Time Frame

72 hours

Title

National Institute of Health Stroke Scale (NIHSS)

Description

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

Time Frame

30 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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: Age: 18-80 years old Ischemic Wake Up Stroke (Unknown time of onset but less than 24 hours since last seen normal) National Institute of Health Stroke Scale (NIHSS) 8-22 Evidence of penumbra on Computed Tomography Perfusion(CTP) as mentioned above Alberta Stroke Program Early Computed Tomography (CT) Score (ASPECTS 7 or more) 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: Evidence of intracranial hemorrhage (Intracerebral hematoma, intraventricular hemorrhage, subarachnoid hemorrhage (SAH), epidural hemorrhage, acute or chronic subdural hematoma (SDH)) on the baseline CT Historical Modified Rankin Scale (mRS) of ≥2 National Institute of Health Stroke Scale (NIHSS)<8 at the time of treatment Positive pregnancy test in women at age of childbearing Intracranial or intraspinal surgery within 3 months Stroke or serious head injury within 3 months History of intracranial hemorrhage Uncontrolled hypertension at time of treatment (eg, >185 mm Hg systolic or >110 mm Hg diastolic) Seizure at the onset of stroke Active internal bleeding Intracranial neoplasm Arteriovenous malformation or aneurysm Clinical presentation suggesting post-MI pericarditis Known bleeding diathesis including but not limited to current use of oral anticoagulants producing an Internation normalized ratio (INR) >1.7 Internation normalized ratio (INR) >1.7 Administration of heparin within 48 hours preceding the onset of stroke with an elevated activated Partial Thromboplastin Time(aPTT) at presentation Platelet count <100,000/mm Major surgery within 2 weeks GastroIntestinal (GI) or urinary tract hemorrhage within 3 weeks Aggressive treatment required to lower blood pressure Glucose level <50 or >400 mg/dL Arterial puncture at a noncompressible site or lumbar puncture within 1 week

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tareq Kass-Hout, MD

Phone

716-887-5548

kasshouttareq@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elad I Levy, MD

Organizational Affiliation

University at Buffalo Neurosurgery

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Tareq Kass-Hout, MD

Organizational Affiliation

Jacobs Neurological Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Millard Fillmore Gates Circle Hospital

City

Buffalo

State/Province

New York

ZIP/Postal Code

14209

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Annemarie Crumlish

Phone

716-887-5548

acrumlish@thejni.org

First Name & Middle Initial & Last Name & Degree

Tareq Kass-Hout, MD

First Name & Middle Initial & Last Name & Degree

Elad Levy, MD

First Name & Middle Initial & Last Name & Degree

Adnan H Siddiqui, MD,PhD

First Name & Middle Initial & Last Name & Degree

Kenneth V Snyder, MD, PhD

First Name & Middle Initial & Last Name & Degree

L N Hopkins, MD

First Name & Middle Initial & Last Name & Degree

Robert N Sawyer, MD

First Name & Middle Initial & Last Name & Degree

Marilou Ching, MD

First Name & Middle Initial & Last Name & Degree

David Janicke, MD

12. IPD Sharing Statement

Learn more about this trial

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

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