Clinical trial NCT02295826 (phase 2, status: completed)
Conditions: transient ischemic attack, minor ischemic stroke
ICD codes: G45.9, Z86.73, G45.8
Drugs: dabigatran, acetylsalicylic acid
SMILES: CCCCCCOC(=O)\N=C(\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1, CC(=O)OC1=CC=CC=C1C(O)=O
Eligibility 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