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)
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|ClinicalTrials.gov Identifier: NCT02329327|
Recruitment Status : Completed
First Posted : December 31, 2014
Last Update Posted : September 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Bleeding||Biological: Andexanet||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||477 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective, Open-Label Study of Andexanet Alfa in Patients Receiving a Factor Xa Inhibitor Who Have Acute Major Bleeding (ANNEXA-4)|
|Actual Study Start Date :||April 10, 2015|
|Actual Primary Completion Date :||September 24, 2020|
|Actual Study Completion Date :||September 24, 2020|
Participants received andexanet as an intravenous bolus administered over ~15 to 30 minutes, followed immediately by a continuous infusion administered over ~120 minutes.
There were 2 possible dosing regimens: Low dose = 400 milligram (mg) bolus plus 4 mg/minute continuous infusion for 120 minutes; High dose = 800 mg bolus plus 8 mg/minute continuous infusion for 120 minutes.
- Proportion of patients with excellent or good hemostasis [ Time Frame: Stopping major bleed at 12 hours from the start of andexanet bolus ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329327