Wake up Symptomatic Stroke in Acute Brain Ischemia (WASSABI) Trial
Overview
- Phase
- Phase 2
- Intervention
- Anti-platelets and statin
- Conditions
- Stroke
- Sponsor
- Jacobs Neurological Institute
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Modified Rankin Scale (mRS)
- Last Updated
- 14 years ago
Overview
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.
Investigators
Tareq Kass-Hout
Chief Vascular/Neurology Resident in charge of stroke
Jacobs Neurological Institute
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
Arms & Interventions
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
Intervention: Anti-platelets and statin
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
Intervention: alteplase
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)
Intervention: intra arterial intervention
Outcomes
Primary Outcomes
Modified Rankin Scale (mRS)
Time Frame: 90 days
Modified Rankin Scale (mRS) 90 days post treatment
Secondary Outcomes
- National Institute of Health Stroke Scale (NIHSS)(30 Days)
- Modified Rankin Scale (mRS)(30 post treatment)
- Thrombolysis In Myocardial Infarction (TIMI) Flow(Pre - up to1 hour prior to procedure and post will be up to1 hour after completion of procedure)
- Thomboylsis in Cerebral Ischemia (TICI) flow(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)(72 hours)