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)

JRCT ID: jRCT2071230071

Registered date:07/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients who require urgent surgery or invasive procedures with a high risk of major bleeding or ble
• Date of first enrollment: 07/11/2023
• Target sample size: 800
• Countries of recruitment: Argentina,Japan,Australia,Japan,Austria,Japan,Belgium,Japan,Brazil,Japan,Bulgaria,Japan,Canada,Japan,China,Japan,Czechia,Japan,Denmark,Japan,Estonia,Japan,Finland,Japan,France,Japan,Georgia,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Korea, Republic of,Japan,Malaysia,Japan,Mexico,Japan,New Zealand,Japan,Poland,Japan,Portugal,Japan,Romania,Japan,Serbia,Japan,Singapore,Japan,Slovakia,Japan,Slovenia,Japan
• Study type: Interventional

Intervention(s)

- Drug: Andexanet alfa
- Andexanet is a recombinant version of human FXa
- Other Names:Andexxa, Ondexxya

- Drug: Usual Care
- As per the label of the chosen usual care product(s) and/or usual care standards.

Outcome(s)

Primary Outcome

-Number of patients achieving effective intraoperative hemostasis [Time Frame: From start to the end of surgery or procedure on Day 0]
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'.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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).

Exclude 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.

Related Information

• Primary Sponsor: Hibi Kazushige
• Secondary ID(s): NCT05926349