ClinicalTrials.gov
ClinicalTrials.gov Menu

Dabigatran Following Transient Ischemic Attack and Minor Stroke (DATAS II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02295826
Recruitment Status : Active, not recruiting
First Posted : November 20, 2014
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Alberta

Brief 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.


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
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Drug: Dabigatran
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Rate of asymtomatic hemorrhagic transformation [ Time Frame: day 30 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients
  2. Must be >18 years of age
  3. Must have TIA or ischemic stroke (NIHSS score <9 - see section 2.7 for further clarification)
  4. 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
  5. 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
  6. All patients will have a MRI including DWI prior to randomization
  7. DWI lesion volume must be <25ml
  8. Patients without DWI lesions, but a clinical history considered consistent with TIA, determined by the attending physician, can be included

Exclusion Criteria:

  1. Patients with stroke mimics - such as seizures, migraine etc
  2. Patients with contraindications to MRI including metallic implants
  3. Patients with any past sensitivity to gadolinium contrast media will be eligible, but will not undergo PWI or contrast enhanced MRA (both optional sequences)
  4. Patients with renal failure defined as Glomerular Filtration Rate (GFR) < 30 ml/min
  5. Patients deemed, as attending stroke physician, to have any ongoing bleeding risks or unsuitable for dabigatran therapy
  6. 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.
  7. Patients with an acute DWI lesion volume of >25 ml (DWI volume to be estimated using the ABC/2 technique 110)**
  8. Age <18 years
  9. Pregnant or breast feeding women.
  10. Severe dysphagia necessitating naso-gastric (NG) feeding (dabigatran can not be delivered via NG tube)
  11. Planned thrombolysis or endovascular intervention for the index event
  12. Thrombolysis for ischemic stroke within the preceding 7 days
  13. 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.
  14. Any history of spontaneous intracranial bleeding
  15. Clear indication for anticoagulation, including atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism or known hypercoagulable state
  16. Co-morbid illness with expected life expectancy of <90 days

Information from the National Library of Medicine

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


Locations
Canada, Alberta
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
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 0A6
Canada, Quebec
Centre Hospitalier de l'Université de Montréal, Hôpital Notre-Dame
Montréal, Quebec, Canada, H2L 4M1
Sponsors and Collaborators
University of Alberta

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT02295826     History of Changes
Other Study ID Numbers: DATAS002
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Stroke
Ischemia
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia
Dabigatran
Aspirin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Platelet Aggregation Inhibitors