Ignite Creation Date:
2024-05-06 @ 7:11 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926349
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-09-07
First Post:
2023-06-09
Brief Title:
A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
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:
NOT_YET_RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ANNEXA-RS
Brief 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 11 to receive either andexanet alfa or usual care
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 11 to receive either andexanet alfa or usual care
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None