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

Intracranial Hemorrhages Clinical Trial

— ASTRO-DE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05127941
• Other study ID #: ASTRO-DE
• Status: Recruiting
• Start date: December 8, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2022
• Source: University Hospital, Essen
• Contact: Hans Diener, Prof. Dr.
• Phone: +49 201 723
• Email: hans.diener[@]uk-essen.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Intracranial Hemorrhages

Locations

Country	Name	City	State
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universitätsklinikum Tübingen	Tübingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety endpoints	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).
Primary	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	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)	before ICH, at admission, at discharge, after 30 days, and after 90 days
Secondary	Mortality rate	Mortality rate after 7, 30 and 90 days, and intra-hospital mortality rate	after 7, 30 and 90 days und during hospital stay
Secondary	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	At hospital admission and additionally at 24 hours and 72 hours after admission
Secondary	Change in severity of stroke	Change in severity of stroke based on the National Institutes of Health Stroke Scale (NIHSS) 72 hours after admission	72 hours after admission
Secondary	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	at baseline
Secondary	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	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
Secondary	Re-dosing and re-anticoagulation therapy	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.
Secondary	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)	Will be recorded during hospital stay until the date of discharge.The average length of hospital stay is expected to be 10 days.