Summary
In elderly or renally impaired volunteers, the antibody fragment idarucizumab rapidly and completely reversed the anticoagulation effect of dabigatran, sustained for at least 24 hours. Re-administration of dabigatran after 24 hours resulted in anticoagulation similar to that observed during initial treatment. There were no clinically relevant drug-related events; infusion-related effects were similar between arms.
- dabigatran antidote
- anticoagulation
- reversal
- idarucizumab
- dabigatran
- Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
- NCT01955720
- © 2014 SAGE Publications