Clinical trial NCT05127941: Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)
Official title: Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Intracranial Hemorrhages
Keywords: Intracranial bleeding
Andexanet-alfa
Rivaroxaban
Apixaban
Anticoagulation
Lead sponsor: University Hospital, Essen
Sponsor class: OTHER
First posted: 2021-11-19
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in size (specified as ml or cm^3) of the intracranial bleeding evaluated by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI)
timeFrame: 12-72 hours after initial CT or MRI, further imaging in case of worsened health condition
Secondary outcomes:
measure: Functional status according to modified Rankin Scale (mRS)
timeFrame: before ICH, at admission, at discharge, after 30 days, and after 90 days
measure: Mortality rate
timeFrame: after 7, 30 and 90 days und during hospital stay
measure: Rate of worsened health condition
timeFrame: At hospital admission and additionally at 24 hours and 72 hours after admission
measure: Change in severity of stroke
timeFrame: 72 hours after admission
measure: Assessment of effective anticoagulation at baseline
timeFrame: at baseline
measure: Clinical course and outcomes of patients
timeFrame: 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
measure: Re-dosing and re-anticoagulation therapy
timeFrame: 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.
measure: Health care resource utilization (including ICU length of stay)
timeFrame: Will be recorded during hospital stay until the date of discharge.The average length of hospital stay is expected to be 10 days.
Other outcomes:
measure: Safety endpoints
timeFrame: 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).
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
Study officials:
affiliation: University Hospital, Essen
name: Hans Diener, Prof. Dr.
role: STUDY_DIRECTOR
References: