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COMPLETEDNCT05127941

Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)

The multicenter, prospective, observational, non-interventional study conducted in German Stroke Units is investigating patients with intracranial hemorrhage (ICH) under effective anticoagulation with...

Lead sponsor: University Hospital, Essen•2 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

University Hospital, Essen

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Age ≥18 years at enrollment
•Patients willing and able to provide written informed consent for data transmission. For patients who are not legally competent to sign this informed consent for data transmission exceptions/special cases are defined (details provided in the study protocol)
•Patients with primary intracranial hemorrhage as confirmed with CT or MRI.
•Patients under effective anticoagulation treatment with rivaroxaban or apixaban at the time of admission, according to the judgement of treating physician and determined using Point-of-care (PoC) anti-factor Xa (fXa) assays or laboratory-based anti-fXa measurement.
•Patients treated with andexanet alfa
•Signed informed consent as soon as possible after start of symptoms of initial ICH event, but before discharge

Exclusion Criteria

•Start of symptoms of initial ICH event \> 24 h before admission to hospital

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 6, 2026Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment141

Start dateDec 2021

Last updatedMay 6, 2026

Condition

Intracranial Hemorrhages

Locations shown

Medizinische Hochschule Hannover

Hanover

Universitätsklinikum Tübingen

Tübingen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 6, 2026Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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