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A trial to learn if andexanet alfa is safe and works to limit bleeding in people who take factor 10a inhibitors and urgently need surgery
EU CTIS ID: 2022-501353-37-00
What this study is testing
To assess the ability of andexanet to achieve effective intraoperative hemostasis when compared to usual care
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Korea, Republic of
- Switzerland
- Japan
- United Kingdom
- Canada
- Australia
- Thailand
- Argentina
- United States
- Malaysia
- Georgia
- Colombia
- New Zealand
- Serbia
- Taiwan
- Singapore
- Mexico
- Brazil
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Korea, Republic of; Switzerland; Japan; United Kingdom; Canada and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.