TEMPO-2 Clinical Trial

TEMPO-2 is a  randomized controlled trial of TNK‐tPA versus standard of care for minor ischemic stroke proven minor ischemic stroke with proven occlusion. 

Study 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. TIA or minor stroke defined as a baseline NIHSS ≤ 5 at the time of randomization. Patients do not have to have persistent demonstrable neurological deficit on physical neurological examination.

4. Any acute intracranial occlusion or near occlusion (TICI 0 or 1) (MCA, ACA, PCA, VB territories) defined by non-­‐invasive acute imaging (CT angiography or MR angiography) that is neurologically relevant to the presenting symptoms and signs. An acute occlusion is defined as TICI 0 or TICI 1 flow.1 Practically this can include a small amount of forward flow in the presence of a near occlusion AND; Delayed washout of contrast with pial vessels on multiphase CTA in a region of brain concordant with clinical symptoms and signs OR, Any area of focal perfusion abnormality identified using CT or MR perfusion – e.g. transit delay (TTP, MTT or TMax), in a region of brain concordant with clinical symptoms and signs.

5. Pre-­‐stroke independent functional status – mRS ≤ 2. 6. Informed consent from the patient or surrogate.

6. Patients can be treated within 90 minutes of the first slice of CT (or MRI)

 

For exclusion criteria and additional info see http://www.ucalgary.ca/dcns/research/tempo-2