Dabigatran Treatment Following Transient Ischemic Attack and Minor Stroke
Status:
Completed
Trial end date:
2014-05-01
Target enrollment:
Participant gender:
Summary
Objective: Demonstrate the safety of early use of dabigatran following TIA/minor stroke.
Background: Although aggressive antithrombotic therapy has been shown to reduce the number of
new ischemic events following stroke/TIA, this has always been offset by an increase in the
risk of hemorrhagic transformation. Dabigatran is much safer than previously tested
antithrombotic agents, with respect to intracranial bleeding and therefore offers a unique
treatment opportunity in these high-risk patients. TIA/minor stroke represent the largest
group of cerebrovascular disease patients. A short-term intervention such as 30 days of
dabigatran treatment has the potential for a very large impact from the population health
perspective, given the number of patients who may be treated if a benefit can be
demonstrated.
Study design:
This is an open label, single arm study. Patients with TIA/minor stroke (National Institutes
of Health Stroke Scale (NIHSS) score 80 years old and/or with
GFR 30-50 ml/min will received 110 mg bid, and all other patients will receive 150 mg
BID).The primary endpoint is symptomatic hemorrhagic transformation. Patients (n=50) with
TIA/minor stroke, defined as having a National Institutes of Health Stroke Scale Score of
/=4 point increase in National Institutes of
Health Stroke Scale (NIHSS) score).
If dabigatran can be used safely in this population, a second phase aimed at demonstrating
the rate of new ischemic lesion development following TIA can be reduced with aggressive
antithrombotic therapy. A randomized open-label, blinded endpoint evaluation design will be
employed. The investigators hypothesize that dabigatran therapy administered within 24 hours
of symptom onset will reduce the rate of new ischemic lesions, relative to standard care, one
week and 30 days after onset.