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

Last updated: December 4, 2024
Sponsor: University Hospital, Essen
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Hemorrhage

Treatment

N/A

Clinical Study ID

NCT05127941
ASTRO-DE
  • Ages > 18
  • All Genders

Study Summary

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

The aim of the study is to analyze under routine conditions wether the volume increase of ICH under treatment with rivaroxaban and apixaban can be reduced with the antidote andexanet alfa. Thus, data of patients under effective treatment with rivaroxaban or apixaban and treated with andexanet alfa at baseline will be assessed at the time of onset of ICH, during the hospital stay and during a follow-up by telephone at 30 and 90 days after hospital discharge.

The main objective is defined as the change in size or volume of the hematoma by computed tomography (CT) or magnetic resonance imaging (MRI) in patients with ICH under effective treatment with rivaroxaban and apixaban, who are treated with andexanet alfa. Further objectives comprise evaluations concerning the functional status according to modified Rankin Scale (mRS), changes in the National Institutes of Health Stroke Scale (NIHSS), and occurrences of ICH or new intraventricular bleeding as well as mortality rates.

Eligibility Criteria

Inclusion

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 datatransmission exceptions/special cases are defined (details provided in the studyprotocol)

  • Patients with primary intracranial hemorrhage as confirmed with CT or MRI.

  • Patients under effective anticoagulation treatment with rivaroxaban or apixaban atthe time of admission, according to the judgement of treating physician anddetermined using Point-of-care (PoC) anti-factor Xa (fXa) assays or laboratory-basedanti-fXa measurement.

  • Patients treated with andexanet alfa

  • Signed informed consent as soon as possible after start of symptoms of initial ICHevent, but before discharge

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 141
Study Start date:
December 08, 2021
Estimated Completion Date:
March 31, 2025

Connect with a study center

  • Medizinische Hochschule Hannover

    Hannover, 30625
    Germany

    Site Not Available

  • Universitätsklinikum Tübingen

    Tübingen, 72076
    Germany

    Site Not Available

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