Primary and secondary efficacy and safety outcomes
| Tenecteplase 0.25 mg/kg (n=43) | Tenecteplase 0.32 mg/kg (n=43) | |
| Primary outcome* (major reperfusion without the occurrence of symptomatic ICH) | 14 (32.6%) | 10 (23.3%) |
| Secondary outcome | ||
| Efficacy | ||
| Recanalisation† | 18 (43.9%) | 18 (43.9%) |
| Infarct growth at 3–5 days, mL‡ | 23.9 (3.5–55.3) | 16.9 (6.7–81.0) |
| Major neurological improvement at 24–48 hours§ | 7 (17.1%) | 8 (18.6%) |
| Change in NIHSS score at 24–48 hours compared with baseline§ | −1.0 (−6.5, 2.0) | 0.0 (−3.0, 2.0) |
| mRS score 0–1 at 90 days | 12 (27.9%) | 21 (48.8%) |
| mRS score 0–2 at 90 days | 20 (46.5%) | 26 (60.5%) |
| mRS score at 90 days | ||
| 0 | 7 (16.3%) | 8 (18.6%) |
| 1 | 5 (11.6%) | 13 (30.2%) |
| 2 | 8 (18.6%) | 5 (11.6%) |
| 3 | 5 (11.6%) | 3 (7.0%) |
| 4 | 7 (16.3%) | 7 (16.3%) |
| 5 | 5 (11.6%) | 5 (11.6%) |
| 6 | 6 (14.0%) | 2 (4.7%) |
| Safety | ||
| Symptomatic ICH | 4 (9.3%) | 4 (9.3%) |
| Any ICH | 21 (48.8%) | 13 (30.2%) |
| Parenchymal haematoma type 2 | 5 (11.6%) | 1 (2.3%) |
| mRS score 5–6 at 90 days | 11 (25.6%) | 7 (16.3%) |
| Systematic haemorrhage | 3 (7.0%) | 1 (2.3%) |
| Barthel Index at 90 days¶ | 95.0 (50.0–100.0) | 95.0 (47.5–100.0) |
Data are n (%), median (IQR).
*Major reperfusion was assessed at the initial catheter angiography or repeated CTP 4–6 hours and symptomatic ICH was assessed at 24–48 hours after intravenous tenecteplase treatment.
†Tenecteplase 0.25 mg/kg: n=41; tenecteplase 0.32 mg/kg: n=41.
‡Tenecteplase 0.25 mg/kg: n=36; tenecteplase 0.32 mg/kg: n=41.
§Tenecteplase 0.25 mg/kg: n=41.
¶Tenecteplase 0.25 mg/kg: n=33; tenecteplase 0.32 mg/kg: n=41.
CTP, perfusion CT; ICH, intracranial haemorrhage; IQR, interquartile range; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.