Research Project
2715391
The implementation of a modified Thrombelastograph Coagulation Analyzer (MTEG(TM)) with a new assay to monitor platelet glycoprotein Ilb/IIla (GPIIb/IIla) receptor blockade in patients being treated with the recently-approved antibody fragment c7E3 Fab is proposed. Based on preliminary results, we are confident that the study will show that the MTEG(TM) can provide an equivalent or better assessment of platelet GPIIb/IIla receptor blockade than the "gold standard" turbidometric platelet aggregation test (aggregation). Phase I research will focus on the study of platelet GPIIb/Illa blockade as measured by MTEG(TM) and aggregation on blood samples of patients undergoing PTCA adjunctive with c7E3 Fab treatment. Inhibition of platelet function, as measured by MTEG(TM), will be correlated with the aggregation response to ADP. Aggregation is a time-consuming test, is expensive to run and requires specially-trained personnel; therefore it is not readily available or practical for routine monitoring or dose individualization. MTEG(TM) can rapidly assay platelet function; it is inexpensive to run and easy to use; and can provide point-of-care monitoring of platelet GPIIb/IIla blockade. Phase II will validate the new test in a larger patient population undergoing PTCA. PROPOSED COMMERCIAL APPLICATIONS: Commercialize the MTEG and accompanying assay to provide a fast and easy- to-use point-of-care test of platelet GPIIb/IIIa blockade.
