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DATAS-II

Official Title

Dabigatran Treatment Following Transient Ischemic Attack and Minor Stroke II

Status

Ongoing

Overview

DATAS-II is an investigator initiated phase II trial which will determine the safety of the novel anticoagulant, dabigatran in patients with TIA or ischemic stroke. Patients will be enrolled within 48 hours of symptom onset and will have an MRI with DWI lesion volume < 25 ml. Patients will be randomized 1:1 to treatment with dabigatran for 30 days or ASA 81 mg daily (current standard of care). The first MRI will be performed within 48 hours of symptom onset and patients will have a repeat MRI at day 30. It is hypothesized that symptomatic HT rates will not be significantly different between the dabigatran and ASA groups.

Study Design

Multicentre, randomized, open label blinded phase II safety trial.

Primary Endpoint

The rate of symptomatic hemorrhagic transformation (HT), defined as a parenchymal hematoma, which is >30% of the infarcted area on DWI, with substantial space-occupying effect, associated with clinical worsening (≥4 point increase in National Institutes of Health Stroke Scale (NIHSS) score) within 5 weeks of treatment initiation.

Number of Patients

305

Number of Sites

6

Number of Countries

1

Study Period

2015-2018

Principal Investigator

Dr. Ken Butcher, University of Alberta; Dr. Mike Sharma, McMaster University/PHRI

Program Manager

Ellison Themeles

Research Coordinator

Jodi Miller

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