Study ID | Country | Study design | Sample size, TNK versus tPA | TNK Dosage | tPA dosage | Time window, h | Key inclusion criteria | Key exclusion criteria |
---|---|---|---|---|---|---|---|---|
Haley et al. 2010 | United States | Phase 2B/3, multicenter, double-blinded, prematurely terminated RCT | 50 versus 31 | 0.1 mg/kg, 0.25 mg/kg, 0.4 mg/kg | 0.9 mg/kg | < 3 | NIHSS > 0; If NIHSS = 1, requires significant deficit | Stroke in last 3 months; Major symptoms which are rapidly improving by the time of treatment |
Parsons et al. 2012 | Australia | Phase 2B, multicenter, PROBE | 50 versus 25 | 0.25 mg/kg | 0.9 mg/kg | < 6 | NIHSS > 4; Occlusion of MCA/ACA/PCA; Perfusion volume > 120% core, and at least 20 ml; Core volume < 1/3 of MCA or 1/2 ACA/PCA territory | Premorbid mRS score ≥ 3; eGFR < 15 ml/min; Evidence of acute brainstem ischemia |
Huang et al. 2015 | Scotland | Phase 2, single center, PROBE | 47 versus 49 | 0.25 mg/kg | 0.9 mg/kg | < 4.5 | Age 18 years or older; NIHSS > 0; Seizure at stroke onset | Premorbid mRS score ≥ 3; eGFR < 30 ml/min |
Logallo et al. 2017 | Norway | Phase 3, multicenter, PROBE | 549 versus 551 | 0.4 mg/kg | 0.9 mg/kg | < 4.5 | Age 18 years or older; NIHSS > 0 | Seizure at stroke onset and no visible occlusion on baseline CT; Clinical stroke < 2 months |
Campbell et al. 2018 | Australia and New Zealand | Phase 2, multicenter, PROBE | 101 versus 101 | 0.25 mg/kg | 0.9 mg/kg | < 4.5 | Age 18 years or older; NIHSS > 0; Occlusion of ICA/MCA/BA | Premorbid mRS score ≥ 3 |
Menon et al. 2022 | Canada | Phase 3, multicenter, PROBE | 806 versus 771 | 0.25 mg/kg | 0.9 mg/kg | < 4.5 | Age 18 years or older; Eligible for endovascular thrombectomy | None |
Kvistad et al. 2022 | Norway | Phase 3, multicenter, PROBE | 100 versus 104 | 0.4 mg/kg | 0.9 mg/kg | < 4.5 | Age 18 years or older; NIHSS ≥ 6 | Premorbid mRS score ≥ 3 |
Li et al. 2022 | China | Phase 2, multicenter, PROBE | 177 versus 59 | 0.1 mg/kg, 0.25 mg/kg, 0.32 mg/kg | 0.9 mg/kg | < 3 | Age 18 years or older; NIHSS 4–25 | Premorbid mRS score ≥ 3 |
Bivard et al. 2022 | Australia | Phase 2, single center, PROBE | 55 versus 49 | 0.25 mg/kg | 0.9 mg/kg | < 4.5 | Age 18 years or older | Premorbid mRS score > 3 |
Wang et al. 2023 | China | Phase 3, multicenter, PROBE | 716 versus 714 | 0.25 mg/kg | 0.9 mg/kg | < 4.5 | Age 18 years or older; NIHSS 5–25 | Premorbid mRS score > 1 |