Wake up Symptomatic Stroke - Benefit of Intravenous Clot... | NCT01455935

NCT01455935

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
University at Buffalo Neurosurgery	OTHER
Genentech, Inc.	INDUSTRY

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medical Therapy	Active Comparator	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	Drug: Anti-platelets and statin
Intravenous Thrombolysis	Experimental	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
Intra-Arterial Therapy	Experimental	-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)	Procedure: intra arterial intervention

Name	Type	Description	Arm Group Labels	Other Names
Anti-platelets and statin	Drug		Medical Therapy
alteplase

Outcomes Module

Measure	Description	Time Frame
Modified Rankin Scale (mRS)	Modified Rankin Scale (mRS) 90 days post treatment	90 days

Secondary Outcomes

Measure	Description	Time Frame
National Institute of Health Stroke Scale (NIHSS)	National Institute of Health Stroke Scale (NIHSS) 24 hours post treatment.	24 hour
National Institute of Health Stroke Scale (NIHSS)	National Institute of Health Stroke Scale (NIHSS) at discharge (3-29 days)

Eligibility Module

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

Name	Affiliation	Role
Elad I Levy, MD	University at Buffalo Neurosurgery	Study Director
Tareq Kass-Hout, MD	Jacobs Neurological Institute	Principal Investigator

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D019161	Hydroxymethylglutaryl-CoA Reductase Inhibitors
D010959	Tissue Plasminogen Activator

ID	Term
D000924	Anticholesteremic Agents
D000960	Hypolipidemic Agents
D000963	Antimetabolites
D045504	Molecular Mechanisms of Pharmacological Action