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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by University of Alberta
Sponsor:
Information provided by (Responsible Party):
Ken Butcher, University of Alberta
ClinicalTrials.gov Identifier:
NCT01769703
First received: February 24, 2012
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

Objective: Demonstrate the safety of early use of dabigatran following TIA/minor stroke.

Background: Although aggressive antithrombotic therapy has been shown to reduce the number of new ischemic events following stroke/TIA, this has always been offset by an increase in the risk of hemorrhagic transformation. Dabigatran is much safer than previously tested antithrombotic agents, with respect to intracranial bleeding and therefore offers a unique treatment opportunity in these high-risk patients. TIA/minor stroke represent the largest group of cerebrovascular disease patients. A short-term intervention such as 30 days of dabigatran treatment has the potential for a very large impact from the population health perspective, given the number of patients who may be treated if a benefit can be demonstrated.

Study design:

This is an open label, single arm study. Patients with TIA/minor stroke (National Institutes of Health Stroke Scale (NIHSS) score </=3) who can be treated within 24 hours of symptom onset will be eligible. All patients will be treated with dabigatran for 30 days. The dose of dabigatran will be determined by age and renal function (patients >80 years old and/or with GFR 30-50 ml/min will received 110 mg bid, and all other patients will receive 150 mg BID).The primary endpoint is symptomatic hemorrhagic transformation. Patients (n=50) with TIA/minor stroke, defined as having a National Institutes of Health Stroke Scale Score of </=3, will undergo an MRI, including diffusion-weighted imaging (DWI), as well as gradient recall echo (GRE) sequences, which will be used to assess for hemorrhagic transformation. Patients will have a repeat MRI examination at 7 and 30 days to assess for hemorrhagic transformation and new lesion development. The primary endpoint of of phase I is symptomatic hemorrhagic transformation, defined as a parenchymal hematoma on the day 7 MRI scan (GRE sequence), associated with clinical worsening (>/=4 point increase in National Institutes of Health Stroke Scale (NIHSS) score).

If dabigatran can be used safely in this population, a second phase aimed at demonstrating the rate of new ischemic lesion development following TIA can be reduced with aggressive antithrombotic therapy. A randomized open-label, blinded endpoint evaluation design will be employed. The investigators hypothesize that dabigatran therapy administered within 24 hours of symptom onset will reduce the rate of new ischemic lesions, relative to standard care, one week and 30 days after onset.


Condition Intervention Phase
Transient Ischemic Attack
Minor Ischemic Stroke
Drug: Dabigatran 110/150 mg BID
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dabigatran Treatment Following Transient Ischemic Attack and Minor Stroke

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Symptomatic Hemorrhagic Transformation [ Time Frame: 30 days post-treatment ] [ Designated as safety issue: Yes ]
    The primary endpoint of phase I is the cumulative incidence of symptomatic hemorrhagic transformation, defined as a parenchymal hematoma on the day 7 and day 30 MRI scans (GRE sequence), associated with clinical worsening (≥4 point increase in National Institutes of Health Stroke Scale (NIHSS) score).


Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran Drug: Dabigatran 110/150 mg BID
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)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients included in the study will have TIA or minor stroke (defined as NIHSS score </= 3).
  • Patients must be treated within 24 hours of symptom onset. In cases where onset time cannot be established, it will be considered to be the time when the patient was last known to be well.
  • All patients will be 18 years or older.
  • All patients will have an MRI, with evidence of at least one DWI lesion, consistent with ischemia, prior to randomization.

Exclusion Criteria:

  • Patients with stroke mimics (such as seizures, migraine etc.) will be excluded from the study.
  • Patients with contraindications to MRI will also be excluded, including metallic implants.
  • Patients with any past sensitivity to gadolinium contrast media will be eligible, but will not undergo PWI.
  • Patients with renal failure, defined as Glomerular Filtration Rate (GFR) <30 ml/min, will be excluded as well.
  • 93 Patients deemed to have any ongoing bleeding risks or unsuitable for dabigatran therapy by the attending stroke clinician will be ineligible.
  • Patients in whom the MRI demonstrates additional pathology including arteriovenous malformations, intracranial aneurysms, tumours, or abscess will be excluded.

Additional Exclusion Criteria:

  • Age <18 years
  • Planned thrombolysis or endovascular intervention for the index event
  • Thrombolysis for ischemic stroke within preceding 7 days
  • Planned carotid endarterctomy/carotid artery stent within 30 days
  • 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 <30 days
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01769703

Contacts
Contact: Ken S Butcher, MD,PhD 780 407 2171 ken.butcher@ualberta.ca

Locations
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G2B7
Contact: Ken S Butcher, MD, PhD    780 407 2171    ken.butcher@ualberta.ca   
Principal Investigator: Ken S Butcher, MD,PhD         
Sub-Investigator: Ashfaq Shuaib, MD         
Sponsors and Collaborators
University of Alberta
  More Information

No publications provided

Responsible Party: Ken Butcher, Associate Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01769703     History of Changes
Other Study ID Numbers: DATAS
Study First Received: February 24, 2012
Last Updated: January 14, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction

ClinicalTrials.gov processed this record on July 20, 2014