AzTrials
AzTrials

Transient Ischemic AttackPhase 2DATAS IINCT02295826

Dabigatran Following Transient Ischemic Attack and Minor Stroke

A Phase 2 study testing Dabigatran and Acetylsalicylic acid in people with Transient Ischemic Attack and Minor Ischemic Stroke, run by University of Alberta at 6 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Dabigatran and Acetylsalicylic acid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
6 sitesCanada
Study dates
Jan 2015to 18 Dec 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patients
  • Must be >18 years of age
  • Must have TIA or ischemic stroke (NIHSS score <9 - see section 2.7 for further clarification)
  • Symptom onset is < 72 hours prior to enrollment or Study therapy must initiated within 48 hours of symptom onset (in case where onset time cannot be established, it will be considered to be the time when the patient was lst know to be well
  • Informed consent must be obtained from either the patient or substitute decision maker (according to local REB policy) prior to any study related procedures being performed
  • All patients will have a MRI including DWI prior to randomization
  • DWI lesion volume must be <25ml
  • Patients without DWI lesions, but a clinical history considered consistent with TIA, determined by the attending physician, can be included

Who cannot join

  • Patients with stroke mimics - such as seizures, migraine etc
  • Patients with contraindications to MRI including metallic implants
  • Patients with any past sensitivity to gadolinium contrast media will be eligible, but will not undergo PWI or contrast enhanced MRA (both optional sequences)
  • Patients with renal failure defined as Glomerular Filtration Rate (GFR) < 30 ml/min
  • Patients deemed, as attending stroke physician, to have any ongoing bleeding risks or unsuitable for dabigatran therapy
  • Patients with MRI demonstrated additional pathology including arteriovenous malformations, intracranial aneurysms, tumors or abscess, which potentially increase the rise of bleed. Individuals with small incidental leasions, at low risk of bleed such as meningiomas may be included at the discretion of the investigator.
Show all 16Show fewer
  • Patients with an acute DWI lesion volume of >25 ml (DWI volume to be estimated using the ABC/2 technique 110)**
  • Age <18 years
  • Pregnant or breast feeding women.
  • Severe dysphagia necessitating naso-gastric (NG) feeding (dabigatran can not be delivered via NG tube)
  • Planned thrombolysis or endovascular intervention for the index event
  • Thrombolysis for ischemic stroke within the preceding 7 days
  • Planned carotid endarterectomy/carotid artery stent within 30 days Note: Carotid Investigations will be completed prior to enrolment. Patients with symptomatic stenoses and a planned carotid procedure will be excluded.
  • Any history of spontaneous intracranial bleeding
  • Clear indication for anticoagulation, including atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable state
  • Co-morbid illness with expected life expectancy of <90 days

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Canada6 sites

  • University of Calgary

    Calgary, Alberta, T2N 2T9

  • University of Alberta

    Edmonton, Alberta, T6G 2B7

  • Grey Nuns Hospital

    Edmonton, Alberta, T6L 5X8

  • Hamilton Health Sciences

    Hamilton, Ontario, L8L 0A6

  • Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame

    Montreal, Quebec, H2L 4M1

  • Vancouver Stroke Program

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

About this study

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.

Read more

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.

Being tested
Dabigatran, Acetylsalicylic acid
Medical subject headings
Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DabigatranDrug

    Also called Pradax (Canada)/ Pradaxa (USA and rest of world)

    Dabigatran will be taken bid for 30 days post enrolment. The dose of dabigatran will be based on patient age and renal function.

  • Acetylsalicylic acidDrug

    Also called Aspirin

    participants randomized to ASA therapy will be loaded with 325 mg of ASA, followed by 81 mg/day

Study groups in NCT02295826
Study groupRoleWhat they receive
Dabigatran therapyExperimental150 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)
Receives: Drug: Dabigatran
Acetylsalicylic Acid thereapyActive comparator325 mg loading dose then 81 mg/day for 30 days
Receives: Drug: Acetylsalicylic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of symptomatic hemorrhagic transformation

    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.

    Measured: within 5 weeks of treatment initiation

Secondary outcomes (1)

  1. Rate of asymtomatic hemorrhagic transformation

    Measured: day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2014 (estimated)
  2. Study startJan 2015
  3. Primary completion18 Dec 2018
  4. Study completion18 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Enrolment
300 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02295826
Sponsor's protocol ID
DATAS002
Acronym
DATAS II
Status last verified
Oct 2018
First submitted
17 Nov 2014
Last updated
30 Jan 2019
Results posted
No
Data monitoring committee
Yes

Publications

  • Cimen E, Ng K, Buck BH, Field T, Coutts SB, Gioia LC, Hill MD, Miller J, Benavente OR, Sharma M, Butcher K. Importance of infarct topography in determination of stroke mechanism and recurrence risk: a post-hoc analysis of the dabigatran acute treatment of stroke trial. BMJ Open. 2025 Jan 9;15(1):e087704. doi: 10.1136/bmjopen-2024-087704.

    PubMed 39788764

  • Alrohimi A, Rose DZ, Burgin WS, Renati S, Hilker NC, Deng W, Oliveira GH, Beckie TM, Labovitz AJ, Fradley MG, Tran N, Gioia LC, Kate M, Ng K, Dowlatshahi D, Field TS, Coutts SB, Siddiqui M, Hill MD, Miller J, Jickling G, Shuaib A, Buck B, Sharma M, Butcher KS. Risk of hemorrhagic transformation with early use of direct oral anticoagulants after acute ischemic stroke: A pooled analysis of prospective studies and randomized trials. Int J Stroke. 2023 Aug;18(7):864-872. doi: 10.1177/17474930231164891. Epub 2023 Mar 26.

    PubMed 36907985

  • Butcher KS, Ng K, Sheridan P, Field TS, Coutts SB, Siddiqui M, Gioia LC, Buck B, Hill MD, Miller J, Klahr AC, Sivakumar L, Benavente OR, Hart RG, Sharma M. Dabigatran Treatment of Acute Noncardioembolic Ischemic Stroke. Stroke. 2020 Apr;51(4):1190-1198. doi: 10.1161/STROKEAHA.119.027569. Epub 2020 Feb 26.

    PubMed 32098609

  • Ng KH, Sharma M, Benavente O, Gioia L, Field TS, Hill MD, Coutts SB, Butcher K; DATAS-2 Investigators. Dabigatran following acute transient ischemic attack and minor stroke II (DATAS II). Int J Stroke. 2017 Oct;12(8):910-914. doi: 10.1177/1747493017711947. Epub 2017 Jun 6.

    PubMed 28585903

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dabigatran and Acetylsalicylic acid in people with Transient Ischemic Attack and Minor Ischemic Stroke, run by University of Alberta at 6 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of symptomatic hemorrhagic transformation (time frame: within 5 weeks of treatment initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02295826, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2019.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in