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

Stroke Clinical Trial

— WASSABI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01455935
• Other study ID #: NEU 3200411A
• Status: Recruiting
• Phase: Phase 2
• First received: October 7, 2011
• Last updated: March 29, 2012
• Start date: November 2011
• Est. completion date: February 2014

Study information

• Verified date: March 2012
• Source: Jacobs Neurological Institute
• Contact: Tareq Kass-Hout, MD
• Phone: 716-887-5548
• Email: kasshouttareq[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Drug:
• Anti-platelets and statin

• 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

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)

Locations

Country	Name	City	State
United States	Millard Fillmore Gates Circle Hospital	Buffalo	New York

Sponsors (3)

Lead Sponsor	Collaborator
Jacobs Neurological Institute	Genentech, Inc., University at Buffalo Neurosurgery

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS) 90 days post treatment	90 days	No
Secondary	National Institute of Health Stroke Scale (NIHSS)	National Institute of Health Stroke Scale (NIHSS) 24 hours post treatment.	24 hour	No
Secondary	National Institute of Health Stroke Scale (NIHSS)	National Institute of Health Stroke Scale (NIHSS) at discharge (3-29 days)	3-29 day	No
Secondary	Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS) at 30 days post treatment	30 post treatment	No
Secondary	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	No
Secondary	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	No
Secondary	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	Yes
Secondary	National Institute of Health Stroke Scale (NIHSS)	at 30 Day visit National Institute of Health Stroke Scale (NIHSS) will be assessed	30 Days	No