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

J

Jacobs Neurological Institute

Status and phase

Unknown
Phase 2

Conditions

Stroke

Treatments

Drug: Anti-platelets and statin
Drug: alteplase
Procedure: intra arterial intervention

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01455935
NEU 3200411A

Details and patient eligibility

About

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.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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:

  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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

Single Blind

90 participants in 3 patient groups

Medical Therapy
Active Comparator group
Description:
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
Treatment:
Drug: Anti-platelets and statin
Intravenous Thrombolysis
Experimental group
Description:
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
Treatment:
Drug: alteplase
Intra-Arterial Therapy
Experimental group
Description:
-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)
Treatment:
Procedure: intra arterial intervention

Trial contacts and locations

1

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Central trial contact

Tareq Kass-Hout, MD

Data sourced from clinicaltrials.gov

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