Apixaban After Anticoagulation-associated Intracerebral Haemorrhage in Patients With Atrial Fibrillation
Status:
Completed
Trial end date:
2021-01-31
Target enrollment:
Participant gender:
Summary
There is a marked lack of evidence on the optimal prevention of ischaemic stroke in patients
with atrial fibrillation and a recent intracerebral haemorrhage (ICH) during treatment with
oral anticoagulation. These patients are currently treated with vitamin K antagonists, DOACs,
antiplatelet drugs, or no antithrombotic treatment, depending on personal and institutional
preferences. Treatment with a direct oral anticoagulant like apixaban might be an attractive
alternative in terms of a low risk of recurrent ICH, while at the same time being effective
for the prevention of ischaemic stroke. This study aims to obtain reliable estimates of the
rates of vascular death or non-fatal stroke in patients with atrial fibrillation and a recent
anticoagulation-associated intracerebral haemorrhage who are treated with apixaban versus
those who are treated with antiplatelet drugs or no antithrombotic drug at all.
This study has a multi-centre, phase II, randomised, open-label clinical trial with blinded
outcome assessment design.
Phase:
Phase 2
Details
Lead Sponsor:
UMC Utrecht
Collaborators:
Dutch Heart Foundation ZonMw: The Netherlands Organisation for Health Research and Development