A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Re… (NCT02329327) | Clinical Trial Compass
CompletedPhase 3
A Study in Participants With Acute Major Bleeding to Evaluate the Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Direct and Indirect Oral Anticoagulants (Extension Study)
United States479 participantsStarted 2015-04-10
Plain-language summary
The purpose of this study was to evaluate the hemostatic efficacy of andexanet alfa (andexanet) in participants receiving a factor Xa (FXa) inhibitor (apixaban, rivaroxaban, edoxaban, enoxaparin) who were experiencing an acute major bleed. The safety of andexanet was also studied.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Acute major bleeding episode that required urgent reversal of anticoagulation; defined by at least one of the following:
✓. If bleeding was intracranial or intraspinal, the participant must have undergone a head computed tomography (CT) or magnetic resonance imaging (MRI) scan demonstrating the bleeding.
✓. Participant received or was believed to have received one of the following within 18 hours prior to andexanet administration: apixaban, rivaroxaban, edoxaban, or enoxaparin.
✓. For participants with intracranial bleeding, there must be a reasonable expectation that andexanet treatment will commence within 2 hours of the baseline imaging evaluation.
Exclusion criteria
✕. The participant was scheduled to undergo surgery in less than 12 hours, with the exception of minimally invasive surgery/procedures.
✕. Participant with an intracerebral hemorrhage that had any of the following:
✕. Participants 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 as follows: venous thromboembolism, myocardial infarction, disseminated intravascular coagulation, 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.
What they're measuring
1
Percent Change From Baseline In Anti-fXa Activity By FXa Inhibitor