Status:
COMPLETED
Dabigatran Following Transient Ischemic Attack and Minor Stroke
Lead Sponsor:
University of Alberta
Conditions:
Transient Ischemic Attack
Minor Ischemic Stroke
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2018
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT02295826
Start Date
January 1 2015
End Date
December 18 2018
Last Update
January 30 2019
Active Locations (6)
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1
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2B7
3
Grey Nuns Hospital
Edmonton, Alberta, Canada, T6L 5X8
4
Vancouver Stroke Program
Vancouver, British Columbia, Canada, V5Z 1M9