CompletedPhase 4

Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor

United States530 participantsStarted 2019-06-06

Plain-language summary

Randomized, controlled clinical trial evaluating the efficacy and safety of andexanet alfa versus usual care in patients with intracranial hemorrhage anticoagulated with a direct oral FXa anticoagulant

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Written informed consent. Either the patient or his or her medical proxy (or legally authorized representative if permissible by local or regional laws and regulations) has been adequately informed of the nature and risks of the study and has given written informed consent prior to Screening.
✓. Age ≥ 18 years old at the time of consent.
✓. An acute intracerebral bleeding episode, defined as an estimated blood volume ≥ 0.5 to ≤ 60 mL acutely observed radiographically within the cerebrum. Patients may have extracerebral (e.g., subdural, subarachnoid, epidural) or extracranial (e.g., gastrointestinal, intraspinal) bleeding additionally, but the intracerebral hemorrhage must be considered the most clinically significant bleed at the time of enrollment.
✓. Performance of a head CT or MRI scan demonstrating the intracerebral bleeding within 2 hours prior to randomization (the baseline scan may be repeated only once to meet this criterion).
✓. Treatment with an oral FXa inhibitor (apixaban \[last dose 2.5 mg or greater\], rivaroxaban \[last dose 10 mg or greater\], or edoxaban \[last dose 30 mg or greater\]):
✓. Time from bleeding symptom onset \< 6 hours prior to the baseline imaging scan. Time of trauma (if applicable) or time last seen normal may be used as surrogates for time of symptom onset. (If the baseline scan is repeated to meet Inclusion Criterion #4, the time from bleeding symptom onset must be \< 6 hours prior to the repeat baseline imaging scan.)
✓. Female patients of childbearing potential and male patients with female partners of childbearing potential must follow protocol-specified guidance for avoiding pregnancy for 30 days after the last dose of study drug.
✓. Have a negative pregnancy test documented prior to enrollment (for females of childbearing potential).

Exclusion criteria

✕. Planned surgery, including Burr holes for hematoma drainage, within 12 hours after randomization. Minimally invasive surgery/procedures not directly related to the treatment of intracranial bleeding and that are not expected to significantly affect hematoma volume are allowed (e.g., Burr holes for intracranial pressure monitoring, endoscopy, bronchoscopy, central lines.
✕. GCS score \< 7 at the time of consent. If a patient is intubated and/or sedated at the time of consent, they may be enrolled if it can be documented that they were intubated/sedated for non-neurologic reasons within 2 hours prior to consent.
✕. Purposefully left blank.
✕. Anticipation that the baseline and follow up brain scans will not be able to use the same imaging modalities (i.e., patients with a baseline CT scan should have a CT scan in follow up; similarly, for MRI).
✕. Expected survival of less than 1 month (not related to the intracranial bleed).
✕. Recent history (within 2 weeks) of a diagnosed TE or clinically relevant symptoms of the following:
✕. Acute decompensated heart failure or cardiogenic shock at the time of randomization.
✕. Severe sepsis or septic shock at the time of randomization.

What they're measuring

Number of Participants Who Achieved Effective Hemostasis

Timeframe: Baseline up to 12 hours

Trial details

NCT IDNCT03661528

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-27

Results submitted2024-05-24

View on ClinicalTrials.gov More Acute Intracranial Hemorrhage trials