Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery

Phase 2 Terminated 10 enrolled Alexion Pharmaceuticals, Inc.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2021-06-27
Primary completion: 2021-11-23
Completion: 2022-01-25

Outcome

Outcome not reported

Stopped: “Limited value as a single-arm study”

Publications

Levy JH, Mamoun N. Direct oral anticoagulants and their antagonists in perioperative practice. Curr Opin Anaesthesiol. 2023 Aug 1;36(4):394-398. doi: 10.1097/ACO.0000000000001275. Epub 2023 Jun 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Andexanet alfa	Protein / enzyme biologic	—	—

Indications

No indication recorded.