Registry of Acute Stroke Under Novel Oral Anticoagulants - Prime (RASUNOA-Prime)

NCT02533960 COMPLETED

The Registry of Acute Stroke Under Novel Oral Anticoagulants-Prime (RASUNOA-Prime), an investigator-initiated study, is a German multicenter, prospective, observational registry. It is performed at about 50 certified stroke-units and supported by an unrestricted grant from different pharmaceutical companies to the Heidelberg University Hospital. RASUNOA-Prime is designed to assess the emergency management of acute ischemic and hemorrhagic stroke patients with atrial fibrillation (AF) under different anticoagulation schemes pre stroke: Non-vitamin K antagonist oral anticoagulants (NOAC), Vitamin K antagonists (VKA), and no anticoagulation.

Details

Lead sponsor	University Hospital Heidelberg
Status	COMPLETED
Enrolment	3832
Start date	2015-06
Completion	2022-06

Conditions

• Ischemic Stroke
• Intracerebral Hemorrhage
• Oral Anticoagulation
• Cardiovascular Diseases
• Vascular Diseases

Interventions

• not applicable (observational study)

Primary outcomes

• Primary hypothesis (ischemic stroke substudy) — Participants will be followed for the duration of hospital stay, an expected average of less than 2 weeks"
  Intracerebral hemorrhage complications (i.e. sICH, according to NINDS and SITS-MOST)
• Primary hypothesis (hemorrhagic stroke substudy) — 24 hours
  Proportion of relevant secondary hematoma expansion on follow-up neuroimaging (hematoma expansion of \>= 33% or 6 mL)

Countries

Germany