Clinical Trials Logo

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


NCT number NCT05127941
Study type Observational
Source University Hospital, Essen
Contact Hans Diener, Prof. Dr.
Phone +49 201 723
Email [email protected]
Status Not yet recruiting
Phase
Start date December 2021
Completion date December 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03969732 - Multimodal Biomarkers for Diagnosis and Prognosis in CAA Phase 3
Recruiting NCT02962349 - TRansfusion Strategies in Acute Brain INjured Patients N/A
Recruiting NCT03950076 - EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF) Phase 3
Completed NCT03542656 - Application of Amyloid PET in Cerebral Amyloid Angiopathy Phase 3
Recruiting NCT04648436 - Evaluation of Surgery in Elderly With Traumatic Acute SubDural Hematoma N/A
Recruiting NCT03495206 - Safety, Tolerability and Pharmacokinetics of Y-2(Edaravone And Borneol) Sublingual Tablet Phase 1
Not yet recruiting NCT04229758 - Restarting Anticoagulation After Traumatic Intracranial Hemorrhage Phase 3
Recruiting NCT02135783 - Decompressive Craniectomy Combined With Hematoma Removal to Treat ICH N/A
Enrolling by invitation NCT02050971 - Autologous Cord Blood Infusion for the Prevention and Treatment of Prematurity Complications In Preterm Neonates Phase 1
Completed NCT01193270 - Vitamin E for Extremely Preterm Infants Phase 1
Completed NCT02881957 - Hypovitaminosis D in Neurocritical Patients Phase 2/Phase 3
Completed NCT03364634 - Intracranial Pressure After Decompressive Craniectomy N/A
Not yet recruiting NCT04459806 - Intracranial PrEssure Time dOse (ImPETO)
Completed NCT00226096 - Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage N/A
Completed NCT03660618 - LSFG-SKIN, Laser Speckle Flowgraphy N/A
Completed NCT02481011 - Risk of Intracranial Hemorrhage in Users of Oral Antithrombotic Drugs
Completed NCT03153150 - Start or STop Anticoagulants Randomised Trial (SoSTART) Phase 3
Recruiting NCT04337697 - Neonatal Seizure Registry - Developmental Functional EValuation
Withdrawn NCT03996317 - Maternal Hyperoxygenation for Intrapartum Fetal Heart Rate Tracing Abnormalities N/A
Active, not recruiting NCT02483169 - PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study Phase 4