Primary and secondary efficacy endpoints at 3 months
| Endpoints N (%) | Present trial | ECASS III trial | |||||
| Alteplase arm (n=120) | Alteplase arm (n=120*) | Placebo arm (n=120*) | OR (95% CI)† | P value† | OR‡ (95% CI) | P value‡ | |
| Primary endpoint | |||||||
| mRS score of 0 or 1 | 76 (63.3) | 74 (61.7) | 68 (56.7) | 1.07 (0.64 to 1.81) | 0.79 | 1.32 (0.79 to 2.22) | 0.29 |
| Secondary endpoint | |||||||
| Global outcome | 66 (55.0) | – | – | – | – | – | – |
| mRS score of 0 or 1 | 76 (63.3) | 74 (61.7%) | 68 (56.7%) | 1.07 (0.64 to 1.81) | 0.79 | 1.32 (0.79 to 2.22) | 0.29 |
| Barthel Index Score ≥95 | 79 (65.8) | 87 (72.5%) | 87 (72.5%) | 0.73 (0.42 to 1.27) | 0.26 | 0.73 (0.42 to 1.27) | 0.26 |
| NIHSS score of 0 or 1 | 68 (56.7) | 72 (60.0%) | 69 (57.5%) | 0.87 (0.52 to 1.46) | 0.60 | 0.97 (0.58 to 1.61) | 0.90 |
| GOS score of 1 | 83 (69.2) | 74 (61.7%) | 69 (57.5%) | 1.39 (0.82 to 2.38) | 0.22 | 1.66 (0.98 to 2.82) | 0.06 |
The OR of alteplase arm in this trial versus ECASS III trial placebo arm.
* Matched groups in the ECASSIII trial to this trial with the Propensity Score Matching (PSM) method,adjusted factors including age, gender, weight, baseline NIHSS score, blood pressure (systolic and diastolic), diabetes, hypertension, atrial flutter or fibrillation, history of stroke, and time to treatment initiation.
†Comparasion between the altplase group in this trial and the matched altplase group in the ECASSIII trial
‡ Comparasion between altplase group in this trial and the matched placebo group in the ECASSIII trial.
ECASS III, European Cooperative Acute Stroke Study III; GOS, Glasgow Outcome Scale; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.