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

Status unconfirmed · Phase 2

Conditions studied: Stroke

In brief

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.

Key facts

Study ID

NCT01455935

Run by

Jacobs Neurological Institute

People needed

90

Starts

2011-11-01

Expected to finish

2014-02-01

Last updated by the study team

2012-03-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Millard Fillmore Gates Circle Hospital — Buffalo, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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