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)

Hibi Kazushige0 个研究点目标入组 800 人开始时间: 2023年10月7日最近更新: 2023年10月17日

适应症

试验速览

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•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).

•- 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.

发起方

Hibi Kazushige