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 Type

Interventional - Drug

Study Design

Randomized, open label, blinded safety trial

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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

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