Interventional - Drug
DATAS-II is an investigator-initiated phase II trial to determine the safety of the novel anticoagulant, dabigatran, in patients with TIA or ischemic stroke.
Patients were enrolled within 48 hours of symptom onset and had an MRI with DWI lesion volume of less than 25 ml.
Patients were randomized 1:1 to treatment with dabigatran for 30 days or ASA 81 mg daily (current standard of care).
The first MRI was performed within 48 hours of symptom onset, and patients had a repeat MRI at day 30. It is hypothesized that symptomatic HT rates will not be significantly different between the dabigatran and ASA groups.
The rate of symptomatic hemorrhagic transformation (HT), defined as a parenchymal hematoma, which is less than 30% of the infarcted area on DWI, with substantial space-occupying effect, associated with clinical worsening (greater than or equal to 4 point increase in National Institutes of Health Stroke Scale score) within five weeks of treatment initiation.
Interventional - Drug
Randomized, open label, blinded safety trial
The Governors of the University of Alberta
Mike Sharma is a stroke neurologist at Hamilton Health Sciences, Associate Professor – Division of Neurology, Department of Medicine, McMaster University, and a scientist in the stroke program at PHRI. He has an interest in clinical trials in secondary stroke prevention, covert stroke, and economics of stroke care.
Mike is Chair of the Canadian Stroke Consortium, and was the Deputy Director for Clinical Affairs and Health Policy of the Canadian Stroke Network, one of Canada’s Networks of Centers of Excellence. He has published more than 31 papers in peer review journals. After completing his fellowship at McGill University and the University of Ottawa, Mike relocated to McMaster University in 2013.
Associate Program Manager
Ellison Themeles’ experience includes more than 20 years in the conduct, execution and management of large, international clinical trials involving both medical devices and pharmaceutical agents in the area of cardiovascular disease and arrhythmias.
She holds a Bachelor of Arts degree in Gerontology and Sociology, and a Master of Science Degree in Health Research Methodology, from McMaster University.
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