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

April 29, 2026 updated by: Prof. Dr. Hans Diener, University Hospital, Essen

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

141

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Tübingen, Germany, 72076
        • Universitatsklinikum Tubingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with anticoagulating therapy with rivaroxaban or apixaban admitted with a clinically symptomatic ICH will be included in the study if they have been treated with andexanet alfa. A repeat CT or MRI between 12-72h after initial imaging to assess size and volume of bleeding corresponds to the standard treatment.

The option to include patients under anticoagulating therapy edoxaban will be evaluated during the course of the study in case a marketing authorization of andexanet alfa for patients under edoxaban will be received.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patient group
Patients under effective anticoagulation with rivaroxaban or apixaban and treated with andexanet alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in size (specified as ml or cm^3) of the intracranial bleeding evaluated by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
Time Frame: 12-72 hours after initial CT or MRI, further imaging in case of worsened health condition
The primary endpoint is the change in size (specified as ml or cm^3) of the intracranial bleeding evaluated by first CT or MRI between 12-72 hours after initial CT or MRI; further imaging in case of worsened health condition
12-72 hours after initial CT or MRI, further imaging in case of worsened health condition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional status according to modified Rankin Scale (mRS)
Time Frame: before ICH, at admission, at discharge, after 30 days, and after 90 days
Functional status acc. to modified Rankin Scale (mRS) before ICH, at admission, at discharge, after 30 days, and after 90 days. The mRS ranges from grade 0 (no symptoms) to grade 6 (dead)
before ICH, at admission, at discharge, after 30 days, and after 90 days
Mortality rate
Time Frame: after 7, 30 and 90 days und during hospital stay
Mortality rate after 7, 30 and 90 days, and intra-hospital mortality rate
after 7, 30 and 90 days und during hospital stay
Rate of worsened health condition
Time Frame: At hospital admission and additionally at 24 hours and 72 hours after admission
Rate of worsened health condition defined as change in NIHSS of ≥4 pts compared to initial NIHSS or worsening of NIHSS level of consciousness ≥1 point or increase of the volume of the intracranial bleeding or new intraventricular bleeding or death
At hospital admission and additionally at 24 hours and 72 hours after admission
Change in severity of stroke
Time Frame: 72 hours after admission
Change in severity of stroke based on the National Institutes of Health Stroke Scale (NIHSS) 72 hours after admission
72 hours after admission
Assessment of effective anticoagulation at baseline
Time Frame: at baseline
Assessment of effective anticoagulation at baseline using PoC anti-fXa assay, intra-hospital decision making for Andexanet alfa administration
at baseline
Clinical course and outcomes of patients
Time Frame: Coagulation parameters will be recorded at hospital admission. Thrombotic events and re-bleeding will be recorded from the date of hospital admission until discharge. The average length of hospital stay is expected to be 10 days
Hemostasis will be assessed by coagulation parameters (activated partial thrombin time (aPTT), thrombin time (TT), International Normalized Ratio (INR)) at admission, re-bleeding and thrombotic events (e.g. myocardial infarction, ischemic stroke, deep vein thrombosis) will be assessed by AE reporting performed from admission to hospital to discharge
Coagulation parameters will be recorded at hospital admission. Thrombotic events and re-bleeding will be recorded from the date of hospital admission until discharge. The average length of hospital stay is expected to be 10 days
Re-dosing and re-anticoagulation therapy
Time Frame: The assessement of re-dosing and re-anticoagulation therapy will take place from the date of hospital admission until the date of discharge. The average length of hospital stay is expected to be 10 days.
Resumption of antithrombotic therapy in hospital (incl. type, start date and dose of anticoagulation therapy)
The assessement of re-dosing and re-anticoagulation therapy will take place from the date of hospital admission until the date of discharge. The average length of hospital stay is expected to be 10 days.
Health care resource utilization (including ICU length of stay)
Time Frame: Will be recorded during hospital stay until the date of discharge.The average length of hospital stay is expected to be 10 days.
Data regarding ICU length of stay and on resource utilization (Intubated on arrival, Mechanical ventilation, ICH-evacuation surgery, External ventricular drainage, Intraventricular lysis, Osmotherapy)
Will be recorded during hospital stay until the date of discharge.The average length of hospital stay is expected to be 10 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety endpoints
Time Frame: Will be recorded at hospital admission, at 24 and 72 hours after admission, at discharge. The average length of hospital stay is expected to be 10 days (depends on the severity of disease and cannot be specifically defined).
Assessment of non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Will be recorded at hospital admission, at 24 and 72 hours after admission, at discharge. The average length of hospital stay is expected to be 10 days (depends on the severity of disease and cannot be specifically defined).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Investigators

  • Study Director: Hans Diener, Prof. Dr., University Hospital, Essen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 8, 2021

Primary Completion (Actual)

April 4, 2024

Study Completion (Actual)

May 26, 2025

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

November 8, 2021

First Posted (Actual)

November 19, 2021

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

April 29, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASTRO-DE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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