Primary Outcome Measures:
- Symptomatic intracerebral hemorrhage (ICH) defined as a greater than or equal to 4-point increase in NIHSS compared to baseline at the time of CT evidence of ICH within 24 hours of study drug administration.
- Recanalization of primary arterial occlusive lesion (AOL) using the Thrombolysis in Myocardial Infarction (TIMI) classification; a score of II or III will be considered success.
Secondary Outcome Measures:
- Relative hypotension requiring treatment (i.e. volume expanders and/or vasopressors)
- New cardiac events (e.g., cardiac ischemia, congestive heart failure, and dysrhythmia)
- Relative hypotension not requiring treatment
- Major bleeding events (TIMI definition)
- Hemorrhagic transformation: hemorrhagic infarction (Type 1 and 2), parenchymal hematoma formation (Type 1 and 2)
- Intracerebral hemorrhage outside of the stroke territory
- New AIS
- AEs/SAEs/All cause mortality
- Changes in chemistry, hematology, coagulation, and alpha-2-macroglobulin parameters based on central laboratory measurements
- Anti-alfimeprase antibody detection based on central laboratory measurements
- Recanalization of the primary AOL
- Global reperfusion of the primary AOL distal vascular bed defined by the Thrombolysis in Cerebral Infarction (TICI) score
- Neurological benefit as assessed by individual and combined analysis of NIHSS, mRS, and BI
Currently approved drug therapy for AIS is limited by the need to treat within 3 hours of symptom onset. Alfimeprase acts to degrade fibrin directly and is inactivated locally by circulating alpha-2 macroglobulin. This study will determine whether treatment with alfimeprase facilitates rapid restoration of arterial blood flow with avoidance of symptomatic hemorrhagic conversion in subjects with AIS within 3 to 9 hours of symptom onset.