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


Phase 2 Results N/A

Eligibility Criteria

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)