Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05898412
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-04-06
Brief Title:
Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
Retrospective Real World Evidence Study to Describe Characteristics and Outcomes in Dutch Patients Admitted to the Hospital With a Factor Xa Inhibitor-associated Bleeding Treated With Andexanet Alfa
Status:
RECRUITING
Status Verified Date:
2024-10
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:
None
Brief Summary:
This is an observational retrospective database study of hospitalized patients treated with andexanet alfa in approximately 10 Dutch hospitals Currently there is limited information on the patient characteristics and outcomes of patients who are treated with andexanet alfa in The Netherlands and how it is used This is of interest for treating clinicians because there is a need for a patient profile also due to the on par position of andexanet alfa with PCC in the Dutch national guideline
Detailed Description:
The direct oral anticoagulants DOAC rivaroxaban and apixaban inhibit factor Xa FXa and are widely used in clinical practice due to the ease of administration lack of need for frequent monitoring and dose adjustment and an improved safety profile However reversal of the anticoagulant effect of these FXa inhibitors FXai can be acutely required in case of serious bleeding events like intracranial hemorrhage ICH
Ondexxya andexanet alfa has been approved and is available in the Netherlands since 2019 Andexanet alfa is a modified FXa with no coagulant activity It has a high binding affinity to DOACs and can therefore be used as reversal agent against DOACs However andexanet alfa is not used in all Dutch centers In some hospitals instead of andexanet alfa nonspecific agents are used to manage FXai-associated ICH bleeding like four-factor prothrombin complex concentrate 4F-PCC
Due to the on par position of andexanet alfa and 4F-PCC in the Dutch multidisciplinary antithrombotic guideline there is no clear patient profiling for the use of andexanet alfa for Dutch clinicians
The lack of randomized clinical trials comparing the efficacy and safety of andexanet alfa and 4F-PCC also does not help to provide clarity There is real world evidence data available Coleman et al 2020 Cohen et al 2022 Costa et al 2022 but these studies uses data from the US and the UK and consistently report a superior effectiveness of andexanet alfa over 4F-PCC However there is considerable variation in the reported effectiveness between these studies with mortality rate ranging from 4 to 153 Potentially differences in methodology and sample size in addition to patient populations and bleeding locations varying between analyses have resulted in this variation Additionally anecdotal information indicates that in some cases andexanet alfa is administered after 4F-PCC fails
Therefore the aim of the present analysis is to characterize the patient population that received andexanet alfa in the Dutch healthcare system Also we aim to describe clinical outcomes in patients treated with andexanet alfa in daily clinical practice in the Netherlands
Providing real world data on the patient characteristics and outcomes of andexanet alfa treated patients in the Netherlands may support clinicians in the future identification of the patient who benefit most of treatment with andexanet alfa
Ondexxya andexanet alfa has been approved and is available in the Netherlands since 2019 Andexanet alfa is a modified FXa with no coagulant activity It has a high binding affinity to DOACs and can therefore be used as reversal agent against DOACs However andexanet alfa is not used in all Dutch centers In some hospitals instead of andexanet alfa nonspecific agents are used to manage FXai-associated ICH bleeding like four-factor prothrombin complex concentrate 4F-PCC
Due to the on par position of andexanet alfa and 4F-PCC in the Dutch multidisciplinary antithrombotic guideline there is no clear patient profiling for the use of andexanet alfa for Dutch clinicians
The lack of randomized clinical trials comparing the efficacy and safety of andexanet alfa and 4F-PCC also does not help to provide clarity There is real world evidence data available Coleman et al 2020 Cohen et al 2022 Costa et al 2022 but these studies uses data from the US and the UK and consistently report a superior effectiveness of andexanet alfa over 4F-PCC However there is considerable variation in the reported effectiveness between these studies with mortality rate ranging from 4 to 153 Potentially differences in methodology and sample size in addition to patient populations and bleeding locations varying between analyses have resulted in this variation Additionally anecdotal information indicates that in some cases andexanet alfa is administered after 4F-PCC fails
Therefore the aim of the present analysis is to characterize the patient population that received andexanet alfa in the Dutch healthcare system Also we aim to describe clinical outcomes in patients treated with andexanet alfa in daily clinical practice in the Netherlands
Providing real world data on the patient characteristics and outcomes of andexanet alfa treated patients in the Netherlands may support clinicians in the future identification of the patient who benefit most of treatment with andexanet alfa
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None