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± 0.21 *

11.3 ±

0.28 *

"*, Mean value ± S.E.M. for 10 individual subjects significantly different from 0.98 ISI thromboplastin means at 5% level by i-t est, separately by increasingly ISI value for individual rabbit thromboplastins.

"*, Mean value ± S.E.M. for 10 individual subjects significantly different from 0.98 ISI thromboplastin means at 5% level by i-t est, separately by increasingly ISI value for individual rabbit thromboplastins.

assay. However, it was not affected to the same degree as was Coumadin. Consequently, using the correction calculation designed for coumadin fluctuations to obtain an INR with CI-1031 grossly exaggerated the INR value. Although INR has been used clinically to monitor anticoagulant status during coumadin therapy, it probably should not be used with FXa inhibitor administration. Coumadin therapy typically produces INR values of 2, 4, and 6 as therapeutic, above therapeutic, and critical levels, respectively. INR values of 10 to 15 may be observed in acute coumadin poisoning, but INR values higher than 15 rarely occur [19]. Clearly, the magnitude of the INR obtained in this experiment (>120 in humans), combined with the incremental increase that occurred with increasing ISI value, shows that INR values in these FXa inhibitor-treated samples were an artifact of the calculation and not associated with the true anticoagulant effects of the FXa inhibitor itself. This suggests that when INR is used in clinical trials, it is important to select a thromboplastin with an ISI value close to 1.0. In this manner, the INR will

TABLE 4 In Vitro Effect of an Experimental Factor Xa Inhibitor on International Normalization Ratio Using a Rabbit Brain Thomboplastin

_ _ International Sensitivity Index" Concentration of Factor ___

TABLE 4 In Vitro Effect of an Experimental Factor Xa Inhibitor on International Normalization Ratio Using a Rabbit Brain Thomboplastin

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