Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya

NCT05898412 | Completed

• 1 other identifier: D9603R00007
• Study Type: observational
• Target: 217
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Hemorrhage

Keywords

Observational; Retrospective; Major bleeding; Andexanet alfa; Factor Xa inhibitor; Patient characteristics; Treatment strategy; Outcomes

Outcome Measures

Primary Outcomes (1)

• Patient characteristics

  At baseline the following patient characteristics will be described: age, sex, type of bleeding (ICH, GI or other), concomittant medication, FXai indication, type and dose, comorbidities, GCS at admission (for ICH only), eGFR and Hb, type of hospital. For 14 TE cases: weight, BMI anti-FXa level, type of blood transfusion, baseline haematoma volume (ICH only), bloodpressure parameters (initial, 1 hr, 2 hr, mean arterial pressure, 24hr control), pulse, noradrenalin, ICH score/Chadvasc score, do not resuscitate status, info on initial hemostasis that could inform on prognosis (if available from CT) will be described

  Baseline (which is the date andexanet alfa is administered, i.e. indexdate)

Secondary Outcomes (6)

• Andexanet alfa dose

  Baseline

• Time from symptom onset to hospital admission

  Baseline

• Time from symptom onset to andexanet alfa administration

  Baseline

• Time between last dose of FXai and andexanet alfa administration

  Baseline

• Frequency that andexanet alfa is administered before or after replacement therapy;

  Baseline

Other Outcomes (14)

• Cumulative incidence of thrombotic events

  from index date to maximum 30 days FU

• Inpatient mortality

  from index date to maximum 30 days FU

• Rehospitalization

  from index date to maximum 30 days FU

Study Arms (2)

Andexanet alfa

Hospitalized patients treated with andexanet alfa

Drug: Andexanet alfa

Thrombotic Event

Hospitalized patients treated with andexanet alfa who experienced a thrombotic event (TE) within 30 days

Drug: Andexanet alfa

Interventions

Andexanet alfa DRUG

Patients treated with andexanet alfa

Andexanet alfa; Thrombotic Event

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Hospitalized patients \>18 years of age treated with at least one dose of andexanet alfa

You may qualify if:

• Age ≥ 18 years
• Received at least one dose of andexanet alfa

You may not qualify if:

• None

Sponsors & Collaborators

• AstraZeneca: lead
• LOGEX Healthcare Analytics Amsterdam The Netherlands: collaborator

Study Sites (1)

Research Site

Amsterdam, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 32618210 BACKGROUND

• 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.

  PMID: 35710578 BACKGROUND

• 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.

  PMID: 35280921 BACKGROUND

Related Links

• Redacted CSR Synopsis

MeSH Terms

Conditions

Hemorrhage

Interventions

PRT064445

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2023
• First Posted: June 12, 2023
• Study Start: October 6, 2023
• Primary Completion: November 25, 2025
• Study Completion: November 25, 2025
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)