TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion (TEMPO-1)

This is an interventional treatment trial for Ischemic Stroke focused on measuring Minor stroke Read More

Inclusion Criteria:

1. Acute ischemic stroke in an adult patient (18 years of age or older)
2. Onset (last-seen-well) time to treatment time < 12 hours.
3. Minor stroke defined as a baseline NIHSS < 6 at the time of randomization. Patients must have a demonstrable neurological deficit on physical neurological examination.
4. Any acute intracranial occlusion (MCA, ACA, PCA, VB territories) defined by non-invasive acute imaging (CT angiography) that is neurologically relevant to the presenting symptoms and signs. An acute occlusion is defined as TICI 0 or TICI 1 flow.
5. Pre-stroke independent functional status in activities of daily living with pre-stroke estimated modified Barthel Index of 90 or greater AND premorbid mRS 0 or 1.
6. Informed consent from the patient or surrogate.
7. Patients can be treated within 90 minutes of the CT/CTA being completed.

Exclusion Criteria:

1. Hyperdensity on NCCT consistent with any intracranial hemorrhage. Any clinical suspicion of any intracranial hemorrhage even in the absence of visible blood on baseline brain imaging.
2. Large acute stroke >1/3 MCA territory or ASPECTS<5 visible on baseline CT scan.
3. Core of established infarction. No area of grey matter hypodensity at a similar or lesser density to white matter or in the judgment of the enrolling neurologist is consistent with a subacute ischemic stroke > 12 hours of age.
4. Clinical history, past imaging and clinical judgment suggest that the intracranial occlusion is chronic.
5. Patient is a candidate for and should receive standard of care IV tPA.
6. Stroke occurring as an in-patient. An in-patient is a person who has been officially admitted to the hospital to a ward bed. A patient in the ED who has not been formally admitted is still considered to be an outpatient.
7. Patient has a severe or fatal or disabling illness that will prevent improvement or follow-up or such that the treatment would not likely benefit the patient.
8. Patient cannot complete follow-up due to co-morbid non-fatal illness or is visiting the host sites city and cannot return for follow-up.
9. Pregnancy.
10. Patient is actively taking dual antiplatelet medication (aspirin & clopidogrel) in the last 48 hours.
11. International normalized ratio > 1.4
12. Standard thrombolysis exclusions (Taken from Canadian guidelines1)

NOTES: NIHSS = National Institutes of Health Stroke Scale ACA = anterior cerebral artery MCA = middle cerebral artery ICA = internal cerebral artery PCA = posterior cerebral artery VB = vertebrobasilar TICI = thrombolysis in cerebral ischemic scale CT = computed tomography NCCT = non-contrast CT CTA = CT angiography ASPECTS = Alberta Stroke Program Early CT Score IV = intravenous tPA = tissue plasminogen activator ED = Emergency Department