Dabigatran Following Transient Ischemic Attack and Minor Stroke
Status:
Completed
Trial end date:
2018-12-18
Target enrollment:
Participant gender:
Summary
Rationale: To date, anticoagulant therapy in acute stroke has also been limited by excess
hemorrhagic events. The oral anticoagulant dabigatran is a novel agent, which has been shown
to be associated with much lower intracranial hemorrhage rates. It has been suggested that
this agent may provide the superior benefits of anticoagulation in acute stroke, without the
concomitant increase in hemorrhage risk associated with heparin/LMWH or warfarin.
Study Design: DATAS II is a randomized, open label blinded endpoint trial. Participants
(n=300) with TIA or ischemic stroke (NIHSS score <9) will be enrolled within 48 hours of
symptom onset from approximately four (4) health care centres across Canada. All participants
will have an MRI with DWI lesion volume < 25 ml. Participants will be randomized 1:1 to
treatment with dabigatran for 30 days or ASA 81 mg daily (current standard of care). All
stroke patients will initially be screened with a non-contrast CT scan of the brain. The
first MRI will be performed within 48 hours of symptom onset. Imaging studies will be
repeated at day 30. All patients will be assessed clinically at Day 30 and Day 90.
Study Aims:
1. Establish the safety of early anticoagulation with the novel oral anticoagulant
dabigatran in acute cerebrovascular syndrome patients.
2. Identify the rate of both symptomatic and asymptomatic hemorrhagic transformation (HT)
associated with these treatments.
3. Identify predictors of HT associated with acute dabigatran treatment.
Hypothesis: The Investigators hypothesize that symptomatic HT rates in dabigatran and ASA
treated patients will not be significantly different.
Study outcomes: The primary outcome is 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. The major secondary outcome the rate of asymtomatic HT see on day 30 MRI
sequence.