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Trial record 1 of 15 for:    andexanet
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Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE) (ASTRO-DE)

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ClinicalTrials.gov Identifier: NCT05127941
Recruitment Status : Recruiting
First Posted : November 19, 2021
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Hans Diener, University Hospital, Essen

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.


Condition or disease
Intracranial Hemorrhages

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Andexanet Alfa: Non-interventional Study in Stroke Units in Germany (DE)
Actual Study Start Date : December 8, 2021
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Group/Cohort
Patient group
Patients under effective anticoagulation with rivaroxaban or apixaban and treated with andexanet alfa



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Functional status according to modified Rankin Scale (mRS) [ Time Frame: before ICH, at admission, at discharge, after 30 days, and after 90 days ]
    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)

  2. Mortality rate [ Time Frame: after 7, 30 and 90 days und during hospital stay ]
    Mortality rate after 7, 30 and 90 days, and intra-hospital mortality rate

  3. Rate of worsened health condition [ Time Frame: At hospital admission and additionally at 24 hours and 72 hours after admission ]
    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

  4. Change in severity of stroke [ Time Frame: 72 hours after admission ]
    Change in severity of stroke based on the National Institutes of Health Stroke Scale (NIHSS) 72 hours after admission

  5. Assessment of effective anticoagulation at baseline [ Time Frame: at baseline ]
    Assessment of effective anticoagulation at baseline using PoC anti-fXa assay, intra-hospital decision making for Andexanet alfa administration

  6. 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 ]
    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

  7. 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. ]
    Resumption of antithrombotic therapy in hospital (incl. type, start date and dose of anticoagulation therapy)

  8. 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. ]
    Data regarding ICU length of stay and on resource utilization (Intubated on arrival, Mechanical ventilation, ICH-evacuation surgery, External ventricular drainage, Intraventricular lysis, Osmotherapy)


Other Outcome Measures:
  1. Safety endpoints [ Time Frame: 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). ]
    Assessment of non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05127941


Contacts
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Contact: Hans Diener, Prof. Dr. +49 201 723 ext 6540 hans.diener@uk-essen.de

Locations
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Germany
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, 30625
Contact: Karin Weißenborn, Prof.         
Universitätsklinikum Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Sven Poli, PD Dr.         
Sponsors and Collaborators
University Hospital, Essen
Investigators
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Study Director: Hans Diener, Prof. Dr. University Hospital, Essen
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Responsible Party: Prof. Dr. Hans Diener, Senior Professor of Clinical Neurosciences, University Hospital, Essen
ClinicalTrials.gov Identifier: NCT05127941    
Other Study ID Numbers: ASTRO-DE
First Posted: November 19, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Hans Diener, University Hospital, Essen:
Intracranial bleeding
Andexanet-alfa
Rivaroxaban
Apixaban
Anticoagulation
Additional relevant MeSH terms:
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Intracranial Hemorrhages
Hemorrhage
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases