A Randomized Study of Andexanet Alfa Compared to Usual Care in Patients Receiving a Factor Xa Inhibitor who Require Urgent Surgery or Procedure (ANNEXA-RS)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501353-37-00

Acronym

D9604C00001

Enrollment

467

Registered

2024-01-10

Start date

Unknown

Completion date

2024-06-13

Last updated

2024-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Reversal of anticoagulation effect in patients on a FXa inhibitor (apixaban, rivaroxaban, or edoxaban) who require urgent surgery or procedure, and who have a major risk of bleeding.

Brief summary

Effective intraoperative hemostasis

Detailed description

Change in anti-FXa activity from baseline to start of surgery or procedure, Change in anti-FXa activity from baseline to 2 h post start of surgery or procedure

Interventions

DRUGFIBRINOGEN

DRUGHUMAN

DRUGRIVAROXABAN

DRUGAPIXABAN

DRUGETAMSYLATE

DRUGTRANEXAMIC ACID

DRUG-

DRUGPROTAMINE

DRUGERYTHROCYTES

DRUGAMINOMETHYLBENZOIC ACID

DRUGAMINOCAPROIC ACID

DRUGOndexxya 200 mg powder for solution for infusion

DRUGEDOXABAN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Effective intraoperative hemostasis	—

Secondary

Measure	Time frame
Change in anti-FXa activity from baseline to start of surgery or procedure, Change in anti-FXa activity from baseline to 2 h post start of surgery or procedure	—

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, Estonia, France, Germany, Greece, Hungary, Ireland, Italy, Lithuania, Poland, Portugal, Romania, Slovakia, Slovenia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026