TerminatedPhase 2

Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery

Stopped: Limited value as a single-arm study

United States10 participantsStarted 2021-06-27

Plain-language 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.

Who can participate

Age range18 Years – 84 Years

SexALL

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Exclusion criteria

✕. The patient has acute-overt bleeding that is potentially life-threatening, e.g., with signs or symptoms of hemodynamic compromise, such as severe hypotension, poor skin perfusion, mental confusion, low urine output that cannot be otherwise explained.
✕. The patient has overt bleeding associated with a fall in hemoglobin level by ≥2g/dL, OR, a hemoglobin ≤8 g/dL if no baseline hemoglobin is available.
✕. The patient has acute bleeding in a critical area or organ, such as pericardial, intracranial, or intraspinal.

What they're measuring

Number of Participants Achieving Effective Hemostasis

Timeframe: Hemostasis will be assessed from the start of surgery to the end of the procedure

Trial details

NCT IDNCT04233073

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-11-23

Results submitted2022-11-21

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