Argatroban Stroke Treatment - A Pilot Safety Study

Exclusion Criteria

• •Evidence of intracranial hemorrhage on baseline CT scan or non-vascular cause of neurologic deficit.
• •National institute health stroke scale (NIHSS) Level of Consciousness score ≥2.
• •Baseline (immediately pre-Argatroban) NIHSS ≤ 5 or patient with rapidly resolving deficit or rapidly improving symptoms consistent with TPA.
• •Baseline NIHSS ≥15 for right hemisphere strokes and ≥20 for left hemisphere strokes.
• •Pre-existing disability with modified rankin scale (mRS) ≥ 2.
• •CT scan findings of hypoattenuation of the x-ray signal (hypodensity)involving ≥ 1/2 of the MCA territory.
• •Any evidence of clinically significant bleeding, or known coagulopathy.
• •Patients currently on warfarin, with an elevated INR ≥ 1.5.
• •Patients currently or within previous 48 hrs. on heparin with an elevated aPTT greater than the upper limit of normal.
• •Heparin flush required for an IV line. Line flushes with saline only.
• •History of ICH or significant bleeding episode within the 3 months before study enrollment.
• •Major surgery or serious trauma within the last 6 weeks.
• •Patients who have had an arterial puncture at a non-compressible site, biopsy of parenchymal organ, or lumbar puncture within the last 2 weeks.
• •Previous stroke, myocardial infarction, post myocardial infarction pericarditis, intracranial surgery, or significant head trauma within 3 months of baseline.
• •Uncontrolled hypertension.
• •Alcohol and/or substance abuse that would increase the risk of hemorrhage in the opinion of the investigator.
• •Surgical intervention anticipated within the next 7 days.
• •Hepatic dysfunction, defined by liver function tests greater than 3 times upper limit of normal at baseline, specifically serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT).
• •Abnormal blood glucose
• •History of primary or metastatic brain tumor.
• •Severe mental deficit prior to onset of stroke such as organic brain disorder, schizophrenia, etc.
• •Concurrent severe neurologic disorder, such as seizure at onset of stroke or uncontrolled seizure disorder that complicates diagnosis of acute ischemic stroke.
• •Current platelet count\< 100,000/mm3.
• •Life expectancy \<3 months in the opinion of the investigator.
• •Need to be on concomitant (i.e, during the Argatroban infusion) anticoagulants other than Argatroban, including any form of heparin, unfractionated heparin (UFH), low molecular weight heparin (LMWH), defibrinogenating agent, dextran, other direct thrombin inhibitors or thrombolytic agents, glycoprotein llb/llla (GPIIb/IIIa) or warfarin.(Caveat: If these anticoagulants can be deferred for 48 hours, then they can be included).
• •Participated in investigational study within 30 days before the first dose of study medication.
• •Hypersensitivity to Argatroban or its agents