Phase 3
N=80
A Study in Older Subject to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Rivaroxaban
Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT02220725 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: 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 Percent change in anti-fXa activity — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Andexanet (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Portola Pharmaceuticals
- Primary completion
- Aug 2015
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 | — |
Summary
The purpose of this study is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Rivaroxaban.
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). 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.