Table of Contents

• Clinical trial overview
• Urgent surgery and bleeding control
• Acute ischemic stroke studies
• Blood clot prevention after hip and knee replacement
• Roux-en-Y gastric bypass and apixaban absorption
• Main outcomes measured in the trials
• Who may be included in these studies

Clinical trial overview

The available studies of Andexanet Alfa are interventional trials, which means the researchers actively assign treatments and then measure outcomes.^{[1][2][2][2][3]}

The trials are mainly in Phase 2 and Phase 3, so they are testing the treatment in larger patient groups and checking both safety and effectiveness.^{[1][2][2][2][3]}

The study topics are different, but they all focus on situations where clotting or bleeding risk matters, such as surgery, stroke, or prevention of venous thromboembolism.^[1][2][2][2]

Urgent surgery and bleeding control

One completed Phase 3 trial studied whether Andexanet Alfa could help achieve effective intraoperative hemostasis, which means good control of bleeding during surgery.^[2]

This study included people taking factor Xa inhibitors, specifically apixaban, rivaroxaban, or edoxaban, who needed urgent surgery or another urgent procedure and had a major risk of bleeding.^[2]

The main outcome was effective intraoperative hemostasis, so the study was focused on whether bleeding could be controlled well during the operation.^[2]

Acute ischemic stroke studies

Another Phase 2 study, called STROACT, looked at people with acute ischemic stroke who were taking a non-vitamin K antagonist oral anticoagulant and then received a specific reversal agent before intravenous rtPA treatment.^[2]

The trial used Andexanet Alfa as the reversal agent in the interventional part of the study, and it examined thrombotic events and death at 90 days as the main safety outcome.^[2]

The observational part of the study measured functional recovery using the modified Rankin scale at 90 days, which helps show how well patients recovered after stroke.^[2]

Blood clot prevention after hip and knee replacement

The DISTINCT trial is a large Phase 3 study in people undergoing total hip or total knee replacement, where the main condition of interest is venous thromboembolism.^[1]

This trial compares different thrombosis prophylaxis, meaning different ways to prevent blood clots after surgery, and includes Andexanet Alfa among the listed interventions.^[1]

The trial has three parts: one for low-risk patients, one for intermediate-risk patients, and one for high-risk patients, with the high-risk group comparing intensified prophylaxis with standard prophylaxis.^[1]

The main outcomes are the number of VTE events and the number of major bleeds in the first 3 months after surgery.^[1]

Roux-en-Y gastric bypass and apixaban absorption

The WENDY study is a small Phase 3 trial in people who have had Roux-en-Y gastric bypass surgery.^[2]

It is designed to compare the pharmacokinetics of apixaban before and after surgery, which means how the body absorbs and processes the medicine over time.^[2]

The main outcome is the area under the curve of anti-Xa levels at several time points from before surgery to 3 months after surgery.^[2]

Andexanet Alfa is one of the interventions listed in this study, along with apixaban and other agents used in the study design.^[2]

Main outcomes measured in the trials

The studies measure different outcomes depending on the clinical setting.^[1][2][2][2]

• Bleeding control: The urgent surgery trial asks whether bleeding can be controlled well during the operation.^[2]

• Thrombotic events and death: The stroke trial checks for clot-related events and death after treatment.^[2]

• Functional recovery: The stroke study also uses the modified Rankin scale to measure recovery at 90 days.^[2]

• VTE and major bleeding: The orthopedic study counts blood clots and major bleeding in the first 3 months after surgery.^[1]

• Anti-Xa levels: The gastric bypass study checks how apixaban exposure changes over time after surgery.^[2]

Who may be included in these studies

The trials focus on different patient groups, not one single disease group.^{[1][2][2][2][3]}

• People on factor Xa inhibitors who need urgent surgery or a procedure and have a major bleeding risk.^[2]

• People with acute ischemic stroke who were taking a non-vitamin K antagonist oral anticoagulant.^[2]

• People undergoing total hip or knee replacement, including low-risk, intermediate-risk, and high-risk groups for venous thromboembolism.^[1]

• People after Roux-en-Y gastric bypass surgery, where apixaban absorption is being studied.^[2]