(rivaroxaban)
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XARELTO® (rivaroxaban)
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XARELTO - Reversal Agents in Human Studies - PCC - Eerenberg et al (2011)
Last updated : 05/16/2024
Eerenberg et al (2011) reported the results of a randomized, double-blind, placebo-controlled, crossover study in 12 healthy male subjects evaluating the effects of PCC (Cofact®) on the reversal of anticoagulant effects of XARELTO.1
Study Design1
XARELTO’s Effect on Coagulation Parameters1
- Mean PT was prolonged from 12.3±0.7 seconds at baseline to 15.8±1.3 seconds.
- ETP was 92%±22% at baseline and was inhibited to 51%±22%.
After PCC Administration1
- PT approximated the baseline value (12.8±1.0 seconds; P<0.001) and was stable over a 24-hour period; saline did not reverse the prolongation of PT that resulted from the administration of XARELTO (16.2±0.8 seconds; P=0.4).
- PCC reversed the inhibition of ETP that was observed after XARELTO administration (114%±26%; P<0.001), but saline did not (41%±6%; P=0.2).
aThe last dose given on the third day was not taken with food.
bA nonactivated PCC was used, and blood was collected for up to 24 hours after PCC infusion.
ETP, endogenous thrombin potential; PCC, prothrombin complex concentrate; PT, prothrombin time.
Reference
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1. Eerenberg ES, Kamphuisen PW, Sijpkens MK, et al. Reversal of rivaroxaban and dabigatran by prothrombin complex concentrate: a randomized, placebo-controlled, crossover study in healthy subjects. Circulation. 2011;124(14):1573-1579.
