Table 1.
Clinical Trials on TNK in Ischemic Stroke
| Name | EXTEND IA TNK II18 | EXTEND IA TNK17 | NOR-TEST16 | ATTEST15 | TAAIS13 | Haley et al12 |
|---|---|---|---|---|---|---|
| Year | 2020 | 2018 | 2017 | 2015 | 2012 | 2010 |
| Study design | PROBE | PROBE | PROBE | PROBE | PROBE | Multi-center, perspective randomized controlled trial |
| Dose | 0.4 mg/kg 0.25 mg/kg |
0.25 mg/kg | 0.4 mg/kg | 0.25 mg/kg | 0.1 mg/kg 0.25 mg/kg |
0.1 mg/kg 0.25 mg/kg 0.4 mg/kg |
| Time window | 4.5h | 4.5h | 4.5h | 4.5h | 6h | 3h |
| Imaging | ICA/MCA/BA occlusion | ICA/MCA/BA occlusion | CTA: intracranial vessel occlusion; CTP: TTP≥core volume 20%, core volume≤20mL | |||
| Sample size | 300 | 202 | 1100 | 96 | 75 | 112 |
| Initial NIHSS | 16 VS 17 | 17 VS 17 | 5.6 VS 5.8 | 12 VS 11 | 14.5 VS 14.6 VS 14 | 8 VS 10 VS 9 VS 13 |
| 90d mRS 0–1 | 49 VS 49%(p=0.69) | 51 VS 43%(p=0.20) | 64% VS 63%(p=0.52) | 28% VS 20%(p=0.28) | 54% VS 40%(p=0.25) | 45.2% VS 48.4% VS 36.8% VS 41.9% |
| Symptomatic intracranial hemorrhage | PH2 36h: 1.3VS. 4.7% (p=0.12) | PH2 36h: 1 VS 1% (p=0.99) | ECASS III: 3 VS 2% (p=0.70) | ECASS III: 6% VS 8% (p=0.59) SITS-MOST: 2% VS 4% (p=0.50) |
SITS-MOST: 4 VS 12% (p=0.33) | 0% VS 6.5% VS 15.8% VS 3.2% |
| Mortality | 15 VS 17% (p=0.35) | 10 VS 18% (p=0.049) | 5 VS 5% (p=0.68) | 17% VS 12% (p=0.51) | 8 VS 12% (p=0.68) | 6.5% VS 22.6% VS 15.8% VS 25.8% |
Abbreviations: TAAIS, Tenecteplase versus Alteplase for Acute Ischaemic Stroke; ATTEST, Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis; NOR-TEST, Norwegian Tenecteplase Stroke Trial; EXTEND-IA TNK, Tenecteplase versus Alteplase before Endovascular Therapy for Ischemic Stroke; PROBE, perspective, randomized, open-label, blind endpoint assessment; TNK, tenecteplase; CTA, computed tomography angiography; CTP, computed tomography perfusion; TTP, time-to-peak; NIHSS, National Institutes of Health Stroke Scale; mRS, modified Rankin Scale; NINDS, National Institute of Neurological Disease and Stroke; ECASS, European Cooperative Acute Stroke Study; SITS-MOST, Safe Implementation of Treatments in Stroke.