At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Canadian Pradaxa Acute Stroke Safety Study
In Brief
An observational study evaluating Dabigatran for Ischemic Attack, Transient and Stroke. Completed, enrolled 101 participants across 2 sites.
Detailed Summary
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.