Background: For decades, oral anticoagulation with vitamin K antagonists (VKA) has been the
sole option for the treatment of a variety of diseases like venous thrombosis, pulmonary
embolism and the prevention of stroke in patients with atrial fibrillation. Despite its
clinical efficacy, the treatment with VKA is associated with multiple well-known limitations,
including a significant risk of major hemorrhages (especially intracerebral hemorrhage), food
and drug interactions, and the need for continued coagulation monitoring for dose control.
Recent randomised controlled trials (RCT) have provided promising results with novel oral
anticoagulants (NOAC) that do not exhibit the limitations of VKA. Especially for stroke
prevention in patients with atrial fibrillation, NOAC have shown comparable or even better
protective efficacy while causing less intracerebral hemorrhages (ICH). Eventually, this has
led to the marketing approval of Apixaban, Rivaroxaban and Dabigatran for stroke prevention
in patients with atrial fibrillation by the Swiss Health Authority (Swissmedic).
Even though the trials reported on the occurrence of acute ischemic strokes or intracerebral
hemorrhages in patients under the treatment with NOAC, only limited data and few case reports
have been published so far. Thus, aspects concerning the treatment decisions and concepts of
management of acute ischemic stroke under NOAC were not addressed in these trials; in
particular, the use of acute revascularisation therapies like intravenous thrombolysis (IVT)
or intra-arterial treatment (IAT) remains unanswered. Furthermore, characteristics,
management and outcome of ICH under the treatment with NOAC were not addressed. Thus,
information on relevant aspects of the management of acute neurovascular emergencies under
NOACs remains scarce.
Aims: The present study will monitor and explore acute neurovascular emergencies in patients
treated with NOACs compared to those under treatment with VKAs. The primary aims of this
study are: (1) To investigate characteristics, management and outcome of intracranial
hemorrhage (ICH) in patients treated with NOAC compared to VKA. (2) To investigate the
management and outcome of patients with acute ischaemic stroke under NOAC compared to VKA.
Methodology: We launch an observational, multi-center (Switzerland and Europe) registry. The
leading and coordinating center is located at the Stroke Center of the University Hospital
Basel. The following groups of patients admitted to a Stroke Unit of one of the participating
centers will be enrolled: A) Patients with ICH occurring while under the treatment with NOAC
(last intake <48 hours) or VKA and B) Patients with acute ischaemic stroke occurring while
under treatment with NOAC (last intake <48 hours) or VKA.
