Dabigatran Following Transient Ischemic Attack and Minor Stroke (DATAS II)
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|ClinicalTrials.gov Identifier: NCT02295826|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : October 16, 2018
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.
- Establish the safety of early anticoagulation with the novel oral anticoagulant dabigatran in acute cerebrovascular syndrome patients.
- Identify the rate of both symptomatic and asymptomatic hemorrhagic transformation (HT) associated with these treatments.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Transient Ischemic Attack Minor Ischemic Stroke||Drug: Dabigatran Drug: Acetylsalicylic acid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Dabigatran Following Transient Ischemic Attack and Minor Stroke|
|Study Start Date :||January 2015|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Dabigatran therapy
150 mg BID for 30 days (dose modification - reduced to 110mg BID in patients >80 years of age and/or an eGFR of 30-50 ml/min)
Dabigatran will be taken bid for 30 days post enrolment. The dose of dabigatran will be based on patient age and renal function.
Other Name: Pradax (Canada)/ Pradaxa (USA and rest of world)
Active Comparator: Acetylsalicylic Acid thereapy
325 mg loading dose then 81 mg/day for 30 days
Drug: Acetylsalicylic acid
participants randomized to ASA therapy will be loaded with 325 mg of ASA, followed by 81 mg/day
Other Name: Aspirin
- Rate of symptomatic hemorrhagic transformation [ Time Frame: within 5 weeks of treatment initiation ]The primary endpoint 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.
- Rate of asymtomatic hemorrhagic transformation [ Time Frame: day 30 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02295826
|University of Calgary|
|Calgary, Alberta, Canada, T2N 2T9|
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2B7|
|Grey Nuns Hospital|
|Edmonton, Alberta, Canada, T6L 5X8|
|Canada, British Columbia|
|Vancouver Stroke Program|
|Vancouver, British Columbia, Canada, V5Z 1M9|
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8L 0A6|
|Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame|
|Montréal, Quebec, Canada, H2L 4M1|