2022-501353-37-00已完成3 期
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)
Astrazeneca AB, Astrazeneca AB81 个研究点 分布在 13 个国家目标入组 467 人开始时间: 2024年1月10日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 467
- 试验地点
- 81
- 主要终点
- Effective intraoperative hemostasis
研究概览
简要总结
To assess the ability of andexanet to achieve effective intraoperative hemostasis when compared to usual care
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-up Visit for patients with positive anti-andexanet antibody test
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Effective intraoperative hemostasis
Effective intraoperative hemostasis
次要结局
- Change in anti-FXa activity from baseline to start of surgery or procedure
- Change in anti-FXa activity from baseline to 2 h post start of surgery or procedure
研究者
AstraZeneca Clinical Study Information Center
Scientific
Astrazeneca AB
研究点 (81)
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