Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya
NCT ID: NCT05898412
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2023-10-06
2025-11-17
Brief Summary
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Analysis of the data showed that 14 patients of the 218 patients included in the study (6.4%) experienced a thrombotic event (TE) within 30 days after treatment with andexanet alfa. The protocol was amended to allow for an in depth analysis of the 14 TE cases.
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Detailed Description
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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 15.3%. 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.
The protocol was amended to allow for an in-depth analysis of the 14 individual cases who experienced a TE within 30 days after treatment with andexanet alfa, in order to establish the temporal relationships and clinical impact/outcome of this event on the patient, stratified by risk factors for the occurrence and outcome of the TE.
The results will be shown in a 'swimmers plot', showing the events relative to the onset of the major bleed and the clinical outcome of the TE, including risk classification based on the presence of co-morbidities and several risk factors such as TE and HF in medical history, weight/BMI, BP, restart DOAC, info on initial hemostasis, ICH/Chadvasc score, etc.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Andexanet alfa
Hospitalized patients treated with andexanet alfa
Andexanet alfa
Patients treated with andexanet alfa
Thrombotic Event
Hospitalized patients treated with andexanet alfa who experienced a thrombotic event (TE) within 30 days
Andexanet alfa
Patients treated with andexanet alfa
Interventions
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Andexanet alfa
Patients treated with andexanet alfa
Eligibility Criteria
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Inclusion Criteria
* Received at least one dose of andexanet alfa
Exclusion Criteria
18 Years
ALL
No
Sponsors
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LOGEX Healthcare Analytics Amsterdam The Netherlands
UNKNOWN
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Research Site
Amsterdam, , Netherlands
Countries
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Central Contacts
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References
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Coleman CI, Dobesh PP, Danese S, Ulloa J, Lovelace B. Real-world management of oral factor Xa inhibitor-related bleeds with reversal or replacement agents including andexanet alfa and four-factor prothrombin complex concentrate: a multicenter study. Future Cardiol. 2021 Jan;17(1):127-135. doi: 10.2217/fca-2020-0073. Epub 2020 Jul 3.
Costa OS, Connolly SJ, Sharma M, Beyer-Westendorf J, Christoph MJ, Lovelace B, Coleman CI. Andexanet alfa versus four-factor prothrombin complex concentrate for the reversal of apixaban- or rivaroxaban-associated intracranial hemorrhage: a propensity score-overlap weighted analysis. Crit Care. 2022 Jun 16;26(1):180. doi: 10.1186/s13054-022-04043-8.
Cohen AT, Lewis M, Connor A, Connolly SJ, Yue P, Curnutte J, Alikhan R, MacCallum P, Tan J, Green L. Thirty-day mortality with andexanet alfa compared with prothrombin complex concentrate therapy for life-threatening direct oral anticoagulant-related bleeding. J Am Coll Emerg Physicians Open. 2022 Mar 5;3(2):e12655. doi: 10.1002/emp2.12655. eCollection 2022 Apr.
Other Identifiers
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D9603R00007
Identifier Type: -
Identifier Source: org_study_id
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