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Clinical Trial Summary

Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.


Clinical Trial Description

This is a multicenter, prospective, open-label study to determine the efficacy and safety of andexanet in patients who require urgent surgery who have received 1 of the following FXa inhibitors: apixaban, rivaroxaban, edoxaban, or enoxaparin. The start of surgery must be within 15 hours following the last dose of FXa inhibitor. The primary efficacy outcome will be adjudicated by an independent Endpoint Adjudication Committee. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04233073
Study type Interventional
Source Alexion
Contact
Status Terminated
Phase Phase 2
Start date June 27, 2021
Completion date January 25, 2022

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