Trials / Terminated
TerminatedNCT04233073
Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery
Prospective, Open-Label Clinical Study of Andexanet Alfa in Patients Receiving FXa (Activated Factor X) Inhibitor Who Require Urgent Surgery
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 10 (actual)
- Sponsor
- Alexion Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 84 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, open-label clinical trial to evaluate the efficacy and safety of andexanet alfa patients who require urgent surgery that have been anticoagulated with the FXa (activated factor X) inhibitors.
Detailed description
This is a multicenter, prospective, open-label study to determine the efficacy and safety of andexanet in patients who require urgent surgery who have received 1 of the following FXa inhibitors: apixaban, rivaroxaban, edoxaban, or enoxaparin. The start of surgery must be within 15 hours following the last dose of FXa inhibitor. The primary efficacy outcome will be adjudicated by an independent Endpoint Adjudication Committee.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | andexanet alfa | Andexanet is a recombinant version of human FXa |
Timeline
- Start date
- 2021-06-27
- Primary completion
- 2021-11-23
- Completion
- 2022-01-25
- First posted
- 2020-01-18
- Last updated
- 2023-03-22
- Results posted
- 2023-03-22
Locations
56 sites across 6 countries: United States, Austria, France, Germany, Israel, Japan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04233073. Inclusion in this directory is not an endorsement.