NCT05926349

A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure

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• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.

Detailed description

This study will be an open-label, randomised, controlled, prospective, multicenter study. The study will include patients requiring urgent surgery or procedure that needs to be performed within 15 hours of the last dose of blood-thinning drug (direct oral activated Factor X (FXa) inhibitor). The study will comprise of the following periods: * Screening, followed by surgery or procedure and study intervention. * Follow-up period: there will be four follow-up visits over a duration of approximately 30 days. * Follow-up visit for patients with positive anti-andexanet alfa antibody test: patients with a positive anti-andexanet alfa antibody response at day 30 will have a follow-up anti-andexanet alfa antibody test approximately 120 days post-surgery or procedure. Patients will be randomised in the ratio of 1:1 to receive either andexanet alfa or usual care.

Conditions

• Urgent Surgery

Interventions

Type	Name	Description
DRUG	Andexanet alfa	Andexanet is a recombinant version of human FXa
DRUG	Usual Care	As per the label of the chosen usual care product(s) and/or usual care standards.

Timeline

• Start date: 2024-08-02
• Primary completion: 2027-01-05
• Completion: 2027-09-07
• First posted: 2023-07-03
• Last updated: 2024-10-26

Regulatory

• FDA-regulated drug study