Key result
Andexanet alfa reversed apixaban-mediated effects on pharmacodynamic markers of anticoagulation in healthy volunteers within minutes after administration (P < .01).
Why the study?
Does andexanet alfa reverse apixaban-mediated effects on pharmacodynamic markers of anticoagulation in healthy volunteers?
RCT
Does andexanet alfa reverse apixaban-mediated effects on pharmacodynamic markers of anticoagulation in healthy volunteers?
p-value: p=< .01
Andexanet alfa rapidly and safely reverses apixaban-induced anticoagulation in healthy volunteers.
Demonstrates rapid biomarker reversal in healthy subjects; leaves open whether this pharmacodynamic effect.
< .01), maintaining these effects during continuous 45- and 120-minute infusions. Andexanet was well tolerated. Nine subjects had mild/moderate infusion reactions not associated with hemodynamic changes or respiratory compromise that generally resolved without intervention or dose reduction. There were no thrombotic events or other serious safety issues. In conclusion, andexanet reversed apixaban-mediated effects on pharmacodynamic markers of anticoagulation in healthy volunteers within minutes after administration and for the duration of infusion. This trial was registered at www.clinicaltrials.gov as #NCT01758432.
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Siegal et al. (2017) conducted an RCT in Healthy volunteers. Andexanet alfa was evaluated on Reversal of apixaban-mediated effects on pharmacodynamic markers of anticoagulation (p=< .01). Andexanet alfa reversed apixaban-mediated effects on pharmacodynamic markers of anticoagulation in healthy volunteers within minutes after administration (P < .01).
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