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

Intracranial Hemorrhages Clinical Trial

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

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05127941
Study type Observational
Source University Hospital, Essen
Contact
Status Active, not recruiting
Phase
Start date December 8, 2021
Completion date December 2024
View Details
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