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
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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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
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.