Intracranial HemorrhagesASTRO-DENCT05127941
Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)
An observational study of Intracranial Hemorrhages, run by University Hospital, Essen at 2 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Hemorrhages
- How many people
- 141 participants
- Where
- 2 sitesGermany
- Study dates
- 8 Dec 2021to 26 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Start of symptoms of initial ICH event > 24 h before admission to hospital
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Medizinische Hochschule Hannover
Hanover, 30625
Universitätsklinikum Tübingen
Tübingen, 72076
About this study
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
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Patients under effective anticoagulation with rivaroxaban or apixaban and treated with andexanet alfa |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
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)
Measured: before ICH, at admission, at discharge, after 30 days, and after 90 days
Mortality rate
Mortality rate after 7, 30 and 90 days, and intra-hospital mortality rate
Measured: after 7, 30 and 90 days und during hospital stay
Rate of worsened health condition
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
Measured: At hospital admission and additionally at 24 hours and 72 hours after admission
Change in severity of stroke
Change in severity of stroke based on the National Institutes of Health Stroke Scale (NIHSS) 72 hours after admission
Measured: 72 hours after admission
Assessment of effective anticoagulation at baseline
Assessment of effective anticoagulation at baseline using PoC anti-fXa assay, intra-hospital decision making for Andexanet alfa administration
Measured: at baseline
Clinical course and outcomes of patients
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
Measured: 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
Resumption of antithrombotic therapy in hospital (incl. type, start date and dose of anticoagulation therapy)
Measured: 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)
Data regarding ICU length of stay and on resource utilization (Intubated on arrival, Mechanical ventilation, ICH-evacuation surgery, External ventricular drainage, Intraventricular lysis, Osmotherapy)
Measured: Will be recorded during hospital stay until the date of discharge.The average length of hospital stay is expected to be 10 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start8 Dec 2021
- Primary completion4 Apr 2024
- Study completion26 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial HemorrhagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Hans Diener, University Hospital, Essen
- Investigators
- Hans Diener, Prof. Dr., Study director, University Hospital, Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127941
- Sponsor's protocol ID
- ASTRO-DE
- Acronym
- ASTRO-DE
- Status last verified
- Apr 2026
- First submitted
- 12 Oct 2021
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39834067
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)
- ClinicalTrials.gov ID
- NCT05127941
- Acronym / sponsor ID
- ASTRO-DE / ASTRO-DE
- Conditions
- Intracranial Hemorrhages
- Keywords
- Intracranial bleeding, Andexanet-alfa, Rivaroxaban, Apixaban, Anticoagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University Hospital, EssenUniversity, hospital or other
- Study start
- 8 Dec 2021 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 26 May 2025 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | –Patients under effective anticoagulation with rivaroxaban or apixaban and treated with andexanet alfa |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Start of symptoms of initial ICH event > 24 h before admission to hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Functional status according to modified Rankin Scale (mRS)
Time frame: 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
Rate of worsened health condition
Time frame: At hospital admission and additionally at 24 hours and 72 hours after admission
Change in severity of stroke
Time frame: 72 hours after admission
Assessment of effective anticoagulation at baseline
Time frame: 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
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 39834067Diener 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Diener, Prof. Dr. study director
University Hospital, Essen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hemorrhages, run by University Hospital, Essen at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127941, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.