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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05926349
Registration number
NCT05926349
Ethics application status
Date submitted
9/06/2023
Date registered
3/07/2023
Date last updated
26/10/2024
Titles & IDs
Public title
A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure
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Scientific title
A Randomized Study of Andexanet Alfa Compared to Usual Care in Patients Receiving a Factor Xa Inhibitor Who Require Urgent Surgery or Procedure (ANNEXA-RS)
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Secondary ID [1]
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D9604C00001
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Universal Trial Number (UTN)
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Trial acronym
ANNEXA-RS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urgent Surgery
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Andexanet alfa
Treatment: Drugs - Usual Care
Experimental: Andexanet Alfa Group - Patients will receive andexanet alfa as IV bolus followed by an infusion.
Active comparator: Usual Care Group - Patients will receive treatment based on the Investigator's discretion, according to regional, local/institutional guidelines or practices.
Treatment: Drugs: Andexanet alfa
Andexanet is a recombinant version of human FXa
Treatment: Drugs: Usual Care
As per the label of the chosen usual care product(s) and/or usual care standards.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of patients achieving effective intraoperative hemostasis
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Assessment method [1]
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Intraoperative hemostasis will be assessed according to the categories as per 4-point hemostasis scale: Excellent - Normal hemostasis, Good - Mildly abnormal hemostasis (eg. slight oozing from surgical wounds), Moderate - Moderate abnormality in intraprocedural hemostasis (eg. controllable bleeding), Poor - Severe hemostatic abnormality (eg. severe refractory hemorrhage). Hemostasis will be considered to be effective if the intraoperative hemostasis category is 'excellent' or 'good', and ineffective if the intraoperative hemostasis category is 'moderate' or 'poor'.
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Timepoint [1]
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From start to the end of surgery or procedure on Day 0
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Secondary outcome [1]
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Change from Baseline in anti-FXa activity measured through blood samples
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Assessment method [1]
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The ability of andexanet alfa to rapidly reverse the anticoagulation effect of FXa inhibitors by reduction of anti-FXa activity when compared to usual care.
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Timepoint [1]
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Baseline to start of surgery or procedure
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Secondary outcome [2]
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Change from Baseline in anti-FXa activity measured through blood samples
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Assessment method [2]
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The ability of andexanet alfa to sustainably reverse the anticoagulation effect of FXa inhibitors by reduction of anti-FXa activity when compared to usual care at two hours post start of surgery or procedure will be assessed.
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Timepoint [2]
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Baseline to two hours post start of surgery or procedure
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Eligibility
Key inclusion criteria
* The patient requires, in the opinion of the Investigator, urgent surgery or procedure and requires reversal of direct oral FXa inhibition.
* The patient requires urgent surgery or procedure within 12 hours of informed consent.
* The patient requires urgent surgery or procedure that is expected to be associated with a high risk of bleeding or bleeding to occur into a critical organ.
* The patient has taken an oral FXa inhibitor (such as apixaban, rivaroxaban, or edoxaban) within 15 hours or more, prior to start of surgery or procedure.
* Female patients of childbearing potential must have a negative pregnancy test at Screening.
* Willingness to use highly effective methods of contraception (for male and female patients who are fertile).
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Minimum age
18
Years
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Maximum age
130
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* The patient requires surgeries or procedures that have a very low chance of causing significant, uncontrollable bleeding, such as small skin procedures, cataract surgery, and minor dental procedures.
* The patient has acute life-threatening bleeding at the time of Screening.
* The patient will undergo a surgery or procedure which will require the use of heparin.
* Patient who is not expected to live for more than three months due to other health problems or has specifically requested not to be resuscitated if their heart stops beating.
* Prior to screening, the patient had either experienced low platelet count due to heparin use with or without blood clots or had a genetic condition that affects blood clotting.
* Patient has acute decompensated heart failure, cardiogenic shock, sepsis, or septic shock at the time of Screening.
* Patient has history of heparin-induced thrombocytopenia (with or without thrombosis) or inherited coagulopathy (eg, anti-thrombin III deficiency, anti-phospholipid antibody syndrome, protein C/S deficiency, Factor V Leiden) at the time of Screening.
* Previously diagnosed with a bleeding disorder (eg, platelet function disorder, hemophilia, Von Willebrand disease, or coagulation factor deficiency).
* Prior known hypersensitivity to andexanet alfa.
* Use of andexanet alfa 30 days prior to Screening.
* Patient diagnosed with dementia.
* Any prohibited medication as determined in the study.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Withdrawn
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
2/08/2024
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
7/09/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
0
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study will aim to find out if the drug andexanet alfa is safe and effective in preventing major bleeding during urgent surgery or invasive procedures. The study will compare the use of andexanet alfa to the usual care given at the study center.
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Trial website
https://clinicaltrials.gov/study/NCT05926349
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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AstraZeneca Clinical Study Information Center
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Address
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Country
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Phone
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1-877-240-9479
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Fax
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Email
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information.center@astrazeneca.com
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05926349
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