Study Type
Interventional - Drug
completed
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.
Primary endpoint:
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.
Study Design
Randomized, open label, blinded safety trial
NO. of Countries
1
NO. of Sites
6
NO. of Participants
305
Study Period
2015-2018
Sponsor
The Governors of the University of Alberta
Canadian Institutes of Health Research (CIHR)
Alberta Innovates Health Solutions
Heart and Stroke Foundation of Alberta, Northwest Territories and Nunavut
Canada Research Chairs Program
Mike Sharma
Scientist
Mike Sharma
Scientist
Mike Sharma, MD MSc FRCPC, is the Director of the Stroke Program at McMaster University and Hamilton Health Sciences and holds the Michael G DeGroote Chair in Stroke Prevention, at McMaster University in Hamilton, Canada. His research interests include the development of new antithrombotic treatments, incorporating magnetic resonance imaging endpoints into the design of stroke prevention trials and examining the effects of anticoagulants on stroke recurrence and covert brain infarcts.
He has led trials and sub-studies in large prevention trials focused on these areas including COMPASS MIND, NAVIGATE ESUS, DATAS II and currently leads as principal investigator, the global phase II AXIOMATIC-SSP trial investigating FXI inhibition for stroke prevention in 27 countries.
He has published more than 140 articles in referred journals, is the immediate past Chair of the Canadian Stroke Consortium, the professional organization for stroke physicians and clinical trialists in Canada and established the stroke program at the University of Ottawa. Dr. Sharma is committed to developing integrated processes for stroke care and developing human and system capacity for the next generation of stroke trials.
Ellison Themeles
Associate Program Manager
Ellison Themeles
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.
Jodi Miller
Project Manager
Jodi Miller
Project Manager
Jodi Miller has more than 15 years experience in academic research. She has been at PHRI since 2012 where she has coordinated large international industry and investigator initiated trials. In her current role she coordinates clinical trials and clinical quality assurance projects in stroke.
Jodi has a BSc in Physics from Mount Allison University and a PhD in Medical Biophysics with a focus on magnetic resonance imaging applications from Western University.
