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

NCT05127941 | Completed

• 1 other identifier: ASTRO-DE
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Intracranial Hemorrhages

Keywords

Intracranial bleeding; Andexanet-alfa; Rivaroxaban; Apixaban; Anticoagulation

Outcome Measures

Primary Outcomes (1)

• Change in size (specified as ml or cm^3) of the intracranial bleeding evaluated by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)

  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 Outcomes (8)

• Functional status according to modified Rankin Scale (mRS)

  before ICH, at admission, at discharge, after 30 days, and after 90 days

• Mortality rate

  after 7, 30 and 90 days und during hospital stay

• Rate of worsened health condition

  At hospital admission and additionally at 24 hours and 72 hours after admission

• Change in severity of stroke

  72 hours after admission

• Assessment of effective anticoagulation at baseline

  at baseline

Other Outcomes (1)

• Safety endpoints

  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).

Study Arms (1)

Patient group

Patients under effective anticoagulation with rivaroxaban or apixaban and treated with andexanet alfa

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Essen: lead

Study Sites (2)

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

Related Publications (1)

• Diener HC, Kuklik N, Husing A, Alonso A, Nabavi DG, Poli S, Gabriel MM, Maier IL, Grans J. Andexanet alfa in patients with factor Xa inhibitor-associated intracranial hemorrhage: The prospective observational multicenter ASTRO-DE study. Int J Stroke. 2025 Aug;20(7):831-842. doi: 10.1177/17474930251317385. Epub 2025 Feb 9.

  PMID: 39834067 RESULT

MeSH Terms

Conditions

Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Hans Diener, Prof. Dr.

  University Hospital, Essen

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Professor of Clinical Neurosciences

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 19, 2021
• Study Start: December 8, 2021
• Primary Completion: April 4, 2024
• Study Completion: May 26, 2025
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

DE (2)