Phase 3
Completed N=80
A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Rivaroxaban
Source: ClinicalTrials.gov NCT02220725 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcomePrimary: Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II) — -18.39; -92.22; -44.75; -96.72 Percent change in anti-fXa activity — p=<0.0001
◆ Published Evidence
Highly cited
1,044citations · ~95 / year
Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity.
Summary
The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Rivaroxaban.
Linked Publications
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Andexanet Alfa for the Reversal of Factor Xa Inhibitor Activity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II) |
-18.39; -92.22; -44.75; -96.72 | <0.0001 sig |
| SECONDARY Efficacy: Percent Change in Anti-fXa Activity (Part II) |
-23.62; -95.34 | <0.0001 sig |
| SECONDARY Efficacy: Number of Participants With ≥80% Reduction in the Anti-fXa Activity From Baseline to Nadir |
0; 26; 0; 26 | — |
| SECONDARY Efficacy: Change From Baseline in Free Rivaroxaban Concentration at the Nadir |
-4.155; -23.347; -12.063; -30.296 | <0.0001 sig |
| SECONDARY Efficacy: Change in Thrombin Generation (ETP) From Baseline to Its Peak [Parts I and II] |
173.861; 1314.193; 264.424; 1510.368 | <0.0001 sig |
| SECONDARY Efficacy: Number of Participants With Thrombin Generation (ETP) Above the Lower Limit of the Derived Normal Range at Its Peak (mITT Population) |
1; 26; 0; 26 | — |
Eligibility Criteria
Inclusion Criteria
- Reasonably healthy men and women aged 50 to 75
Exclusion Criteria
- History of abnormal bleeding, active bleeding or risk factors for bleeding
- History of thrombosis or risk factors for thrombosis
- History of adult asthma or use of inhaled medications
Data sourced from ClinicalTrials.gov (NCT02220725) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.