Argatroban TPA Stroke Study [SPOTRIAS] "ARTTS"


Phase N/A Results

Eligibility Criteria

Inclusion Criteria

Ischemic stroke symptoms with onset ? 3 hours; clot causing complete or partial occlusion via TCD in any one of the following areas: distal ICA, MCA, PCA distal vertebral or basilar occlusions. TCD must be abnormal prior to the start of Argatroban; females of childbearing potential must have a negative serum pregnancy test prior to the administration of trial medication; meet criteria for rt-PA therapy.

Exclusion Criteria

Evidence of intracranial hemorrhage on baseline CT scan or non-vascular cause of neurologic deficit; NIHSS Level of Consciousness score ?2; baseline 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 mRS ? 2; CT scan findings of hypoattenuation of the x-ray signal involving at least 2 lobes of the brain an at least 1/2 of the MCA territory; absent temporal windows on TCD; 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 SGOT and 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; current platelet count< 100,000/mm3; life expectancy <3 months in the opinion of the investigator; need for concomitant use of anticoagulants other than Argatroban, including any form of heparin, UFH, LMWH, defibrinogenating agent, dextran, other direct thrombin inhibitors or thrombolytic agents, GPIIb/IIIa or warfarin; currently participating or has participated in any investigational drug or device study within 30 days before the first dose of study medication; known hypersensitivity to Argatroban or its agents.