Study Design:
This is a multicentre, prospective, open-label, single arm, phase IV registry study. No
additional procedures are included in the study. Standard clinical data will be collected.
This will include a physical examination and NIHSS score assessment at baseline. In addition,
all neuro-imaging will be collected. Standard imaging includes a non-contrast CT brain at
baseline and 7±2 days post-treatment. Repeat NIHSS score assessment at the time of the 7 day
CT scan. Repeat clinical and NIHSS score assessment 30 days post-enrolment will also be
collected when performed as part of standard care.
Study Objectives:
1. Demonstrate the safety of early dabigatran initiation after minor stroke/TIA in patients
with atrial fibrillation.
2. Determine the frequency of asymptomatic hemorrhagic transformation after 7 days of
dabigatran treatment following stroke/TIA
3. Determine the effect of asymptomatic hemorrhagic transformation on functional and
neurological outcome at 30 days.