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) - D9604C00001

Astrazeneca AB0 个研究点目标入组 1,021 人开始时间: 2023年8月30日最近更新: 2024年7月22日

试验速览

暂无简介。

•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, Use of andexanet alfa 30 days prior to Screening, Patient diagnosed with dementia, Any prohibited medication as determined in the study, 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

发起方