Table 3.
Ongoing Trials of TNK in Ischemic Strokes
| Abbreviation | Study Name | Study ID | Time Window | Target Imaging Mismatch | Intervention | Sample Size | Study Design | Study Time | Primary Endpoints |
|---|---|---|---|---|---|---|---|---|---|
| TWIST | Tenecteplase in Wake-up Ischaemic Stroke Trial | NCT03181360 | 4.5h from awakening | 0.25mg/kg TNK vs best standard treatment | 600 | PROBE | 2017–2022 | 90d mRS score | |
| NOR-TEST 2 | The Norwegian Tenecteplase Stroke Trial 2 |
NCT03854500 | 4.5h from onset/awakening | 0.4mg/kg TNK vs 0.9mg/kg alteplase | 1342 | PROBE, non-inferiority | 2019–2024 | 90d mRS 0–1 | |
| ROSE-TNK | MRI-guided thrOmbolysis for Stroke bEyond Time Window by TNK | NCT04752631 | 4.5–24h | DWI-FLAIR mismatch | 0.25mg/kg TNK vs best standard treatment | 80 | PROBE | 2021–2022 | 90d mRS 0–1 |
| TIMELESS | Tenecteplase in Stroke Patients Between 4.5 and 24 Hours | NCT03785678 | 4.5–24h | CT/MR perfusion mismatch (ischemic core volume <70 mL, mismatch ratio is ≥1.8 and mismatch volume is ≥ 15 mL) | 0.25mg/kg TNK vs placebo | 456 | Double-blind, randomized, placebo-controlled | 2019–2022 | 90d mRS score |
| TRACE III | Teneteplase Reperfusion Therapy in Acute Ischemic Cerebrovascular Events-III | NCT05141305 | 4.5–24h | CT perfusion or MRI_perfusion weighted imaging mismatch (ischemic core volume <70 mL, mismatch ratio≥1.8 and mismatch volume≥15 mL) | 0.25mg/kg TNK vs best standard treatment | 516 | PROBE | 2022–2023 | 90d mRS 0–1 |
| CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase II | NCT04516993 | 4.5–24h | Perfusion lesion volume (DT > 3 s) to infarct core volume ratio (rCBF<30% or diffusion-weighted imaging lesion) >1.2, absolute difference >10 mL, and ischemic core volume <70mL | 0.25mg/kg TNK vs nonthrombolysis drug | 224 | PROBE | 2021–2022 | 90d mRS change | |
| TEMPO-2 | A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion | NCT02398656 | 12h | 0.25mg/kg TNK vs best standard treatment | 1274 | PROBE | 2015–2023 | 90d mRS score | |
| CHABLIS-T | CHinese Acute Tissue-Based Imaging Selection for Lysis In Stroke -Tenecteplase | NCT04086147 | 4.5–24h | Perfusion lesion volume (DT > 3 s) to infarct core volume ratio (rCBF<30% or diffusion-weighted imaging lesion) >1.2, absolute difference >10 mL, and ischemic core volume <70mL | 0.25mg/kg TNK vs 0.32mg/kg TNK | 86 | PROBE | 2019–2021 | Patients without endovascular therapy obtained >50% reperfusion at 4–6 hours; Patients with endovascular therapy: mTICI score 2b or better at initial angiogram; No symptomatic intracranial hemorrhage at 24–36 hours |
| ETERNAL-LVO | Extending the Time Window for Tenecteplase by Effective Reperfusion in Patients With Large Vessel Occlusion | NCT04454788 | 24h | CT/MR perfusion mismatch (ischemic core of <70mL, penumbra of >20mL and an ischemic core to perfusion lesion ratio of >1.8) | 0.25mg/kg TNK vs best standard treatment | 740 | PROBE | 2020–2025 | 90d mRS 0–1 or return to baseline mRS |
| TASTEa | Tenecteplase Versus Alteplase for Stroke Thrombolysis Evaluation Trial in the Ambulance | NCT04071613 | 4.5h | 0.25mg/kg TNK vs 0.9mg/kg alteplase | 80 | PROBE | 2019–2021 | The volume of the perfusion lesion on CTP performed on arrival at the receiving hospital | |
| ATTEST2 | Alteplase-Tenecteplase Trial Evaluation for Stroke Thrombolysis | NCT02814409 | 4.5–24h | 0.9mg/kg alteplase vs 0.25mg/kg TNK | 1870 | Open-label, randomized, placebo-controlled | 2016–2019 | 90d mRS score |
Abbreviations: TNK, tenecteplase; PROBE, prospective, randomised open-label blinded endpoint; DT, delay time; rCBF, relative cerebral flow; mTICI, modified thrombolysis in cerebral infarction.