Inclusion CriteriaPatients must meet all of the inclusion criteria.
1. Diagnosis of acute ischemic stroke defined as a measurable neurological deficit of sudden onset, presumed secondary to focal cerebral ischemia.
2. Disabling neurological deficit attributable to acute ischemic stroke.
3. NIHSS less than or equal to 18 for left hemisphere strokes, NIHSS less than or equal to 16 for others.
4. A score of at least 3 on item 6 of the NIHSS (motor score leg) pre-treatment.
5. Age 18-85 years, inclusive.
6. Able to sign informed consent.
Exclusion CriteriaPatients will be excluded from study participation for any of the following reasons:
1. Current participation in another study with an investigational drug or device within, prior participation in the present study, or planned participation in another therapeutic trial, prior to the final (day 90) assessment in this trial.
2. Symptoms suggestive of subarachnoid hemorrhage, even if CT or MRI scan is negative for hemorrhage.
3. Women known to be pregnant, lactating or having a positive or indeterminate pregnancy test.
4. Neurological deficit that has led to stupor or coma (NIHSS level of consciousness [item I a] score greater than or equal to 2).
5. Minor stroke with non-disabling deficit or rapidly improving neurological symptoms.
6. Baseline NIHSS greater than 18 for left hemisphere stroke or greater than 16 for others.
7. Evidence of acute or chronic ICH by head CT or MRI.
8. CT or MRI evidence of non-vascular cause for the neurological symptoms.
9. Signs of mass effect causing shift of midline structures on CT or MRI.
10. Any intracranial surgery, intraspinal surgery, or serious head trauma (any head injury that required hospitalization) within the past 3 months.
11. Stroke within the past 3 months.
12. Presence or history of intracranial neoplasm (except small meningiomas) or arteriovenous malformation.
13. Intracranial aneurysm, unless surgically or endovascularly treated more than 3 months before.
14. Seizure at the onset of stroke or a history of epilepsy.
15. Life expectancy less than 3 months.
16. Other serious illness, e.g., severe hepatic, cardiac, or renal failure; acute myocardial infarction; or complex disease that may confound treatment assessment.
17. Treatment of the qualifying stroke with any thrombolytic, anti-thrombotic or GPIIbIIIa inhibitor outside of this protocol.