A Study in Patients With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Know the risks and potential benefits of clinical studies and talk to your health care provider before participating.
Read our disclaimer for details.
The purpose of this study is to evaluate the hemostatic efficacy of andexanet alfa in patients receiving a factor Xa inhibitor who are experiencing an acute major bleed. The safety of andexanet will also be studied.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Acute major bleeding episode requiring urgent reversal of anticoagulation; defined by at least one of the following:
Acute bleeding that is potentially life-threatening, OR
Acute bleeding associated with a fall in hemoglobin level by ≥2 g/dL, OR
Acute bleeding associated with a hemoglobin level of ≤8 g/dL if no baseline hemoglobin is available, OR
Acute bleeding in a critical area or organ such as intraspinal, pericardial, or intracranial.
If bleeding is intracranial or intraspinal, the patient must have undergone a head CT or MRI scan demonstrating the bleeding.
Patient received or is believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban or enoxaparin.
For patients with intracranial bleeding, there must be a reasonable expectation that andexanet treatment will commence within 2 hours of the baseline imaging evaluation.
The patient is scheduled to undergo surgery in less than 12 hours, with the exception of minimally invasive surgery/procedures.
A patient with an intracerebral hemorrhage has any of the following:
Glasgow coma score < 7, OR
Intracerebral hematoma > 60 cc as assessed by CT or MRI
Patients with visible, musculoskeletal or intra-articular bleeding as their qualifying bleed.
Expected survival of less than 1 month
Recent history (within 2 weeks) of a diagnosed thrombotic event (TE) as follows: venous thromboembolism, myocardial infarction, disseminated intravascular coagulation (DIC), cerebral vascular accident, transient ischemic attack, unstable angina pectoris hospitalization or severe peripheral vascular disease within 2 weeks prior to screening.
Severe sepsis or septic shock at the time of Screening.
Pregnant or a lactating female.
Patient has received any of the following drugs or blood products within 7 days of Screening:
Vitamin K antagonist (VKA)
Prothrombin Complex Concentrate products (PCC) or recombinant factor VIIa (rfVIIa)
Whole blood, plasma fractions
Treated with an investigational drug <30 days prior to Screening
Planned administration of PCC, fresh frozen plasma (FFP) or rfVIIa from Screening until within 12 hours after the end of the andexanet infusion.