Forecast of Functional Outcome and Impact of Anti Factor Xa-levels in Patients With Intracerebral Haemorrhage Related to Direct Factor Xa Inhibitors - a Multi-center Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This study focuses on direct factor Xa inhibitors (apixaban, edoxaban, rivaroxaban) and the thrombin inhibitor dabigatran, commonly used for stroke prevention in atrial fibrillation. Despite lower intracranial bleeding risks with these drugs, around 0.2-1.0% of patients annually experience intracranial hemorrhage (ICH), predominantly intracerebral. Treatment options for factor-Xa inhibitor-associated ICH, such as prothrombin complex concentrate (PCC) and andexanet alfa, lack direct comparison evidence except for ongoing trials like ANNEXA-I. This trial assesses hemostatic efficacy and 30-day functional outcomes but leaves gaps regarding anticoagulant activity's role and long-term effects, especially in patients presenting late after drug intake. The measurement of anti-FXa levels helps guide decisions, yet their link to hematoma expansion remains unknown. Efforts to streamline measurement within 30 minutes for acute decisions have shown variability in levels, with some patients exhibiting high levels even beyond 12 hours post-intake. This lack of data poses challenges, particularly for patients potentially benefiting from treatment beyond the current strict time window. Early hematoma expansion strongly predicts poor outcomes, but preventing it faces challenges like recurrent events (up to 5% by 3 months) and rehabilitation intensity, potentially negating its benefits. The ANNEXA-I trial evaluates short-term outcomes, highlighting the need for additional data to comprehend long-term ICH prognosis. The study's objectives involve linking hematoma expansion to anti-FXa levels, determining late-presenting patients' risk of expansion, and identifying predictors of favorable outcomes at 3, 6, and 12 months. Primary endpoints include functional outcomes, while secondary ones encompass expansion rates, anticoagulant activity, and various events at 12 months. This research aims to bridge gaps in understanding factor-Xa inhibitor-related ICH, addressing both immediate and prolonged outcomes to enhance clinical decision-making.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Imaging proven intracerebral haemorrhage

• Prior therapy with a factor Xa-inhibitor (apixaban, edoxaban or rivaroxaban), not paused for medical/non-medical reasons for more than 48 hours prior to symptom onset

• Drug-specific calibrated anti-FXa levels measured on admission

• Informed consent (by patient, next-of-kin or deferred consent)

Locations
Other Locations
Switzerland
Insel Gruppe AG, Inselspital Bern
RECRUITING
Bern
Contact Information
Primary
David J. Seiffge
david.seiffge@insel.ch
+41 31 66 4 12 31
Backup
Janis P. Rauch
janispatricia.rauch@insel.ch
Time Frame
Start Date: 2023-07-10
Estimated Completion Date: 2026-04-01
Participants
Target number of participants: 200
Treatments
ICH study cohort
Patients with intracerebral haemorrhage associated with factor Xa-inhibitor treatment treated at one of the participating centres.
Related Therapeutic Areas
Sponsors
Leads: Insel Gruppe AG, University Hospital Bern

This content was sourced from clinicaltrials.gov