Phase 3
N=68
A Study in Older Subjects to Evaluate the Safety and Ability of Andexanet Alfa to Reverse the Anticoagulation Effect of Apixaban
Bleeding
Bottom Line
View on ClinicalTrials.gov: NCT02207725 ↗Enrolled (actual)
68
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) — -20.71; -93.86; -32.70; -92.34 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
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Parts I and II) |
-20.71; -93.86; -32.70; -92.34 | <0.0001 sig |
| SECONDARY Efficacy: Percent Change From Baseline in Anti-fXa Activity at the Nadir (Part II) |
-16.73; -93.49 | <0.0001 sig |
| SECONDARY Efficacy: Number of Participants With ≥80% Reduction in the Anti-fXa Activity From Baseline to Nadir |
0; 24; 0; 23 | — |
| SECONDARY Efficacy -Change From Baseline in Free Apixaban Concentration at the Nadir |
-1.854; -9.338; -2.964; -6.480 | <0.0001 sig |
| SECONDARY Efficacy: Change in Thrombin Generation (ETP) From Baseline to Its Peak [Parts I and II] |
88.182; 1323.180; 189.409; 1193.060 | <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; 24; 2; 23 | — |
Summary
The purpose of this stuy is to evaluate the ability of Andexanet Alfa to reverse the anticoagulation effect of Apixaban.
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 (NCT02207725). 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.