Dabigatran Treatment Following Transient Ischemic Attack and Minor Stroke (DATAS)
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.
This is an open label, single arm study. Patients with TIA/minor stroke (National Institutes of Health Stroke Scale (NIHSS) score </=3) who can be treated within 24 hours of symptom onset will be eligible. All patients will be treated with dabigatran for 30 days. The dose of dabigatran will be determined by age and renal function (patients >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 </=3, will undergo an MRI, including diffusion-weighted imaging (DWI), as well as gradient recall echo (GRE) sequences, which will be used to assess for hemorrhagic transformation. Patients will have a repeat MRI examination at 7 and 30 days to assess for hemorrhagic transformation and new lesion development. The primary endpoint of of phase I is symptomatic hemorrhagic transformation, defined as a parenchymal hematoma on the day 7 MRI scan (GRE sequence), associated with clinical worsening (>/=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.
Transient Ischemic Attack
Minor Ischemic Stroke
Drug: Dabigatran 110/150 mg BID
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Dabigatran Treatment Following Transient Ischemic Attack and Minor Stroke|
- Symptomatic Hemorrhagic Transformation [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: Yes ]The primary endpoint of phase I is the cumulative incidence of symptomatic hemorrhagic transformation, defined as a parenchymal hematoma on the day 7 and day 30 MRI scans (GRE sequence), associated with clinical worsening (≥4 point increase in National Institutes of Health Stroke Scale (NIHSS) score).
|Study Start Date:||February 2012|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Drug: Dabigatran 110/150 mg BID
Dabigatran will be taken bid for 30 days post enrolment. The dose of dabigatran will be based on patient age and renal function.
Other Name: Pradax (Canada)/ Pradaxa (USA and rest of world)
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|Contact: Ken S Butcher, MD,PhD||780 407 firstname.lastname@example.org|
|University of Alberta||Recruiting|
|Edmonton, Alberta, Canada, T6G2B7|
|Contact: Ken S Butcher, MD, PhD 780 407 2171 email@example.com|
|Principal Investigator: Ken S Butcher, MD,PhD|
|Sub-Investigator: Ashfaq Shuaib, MD|