Article Figures & Data
Figures
- Figure 1
Comparation of the function outcome by the 3-month mRS in this trial to the matched ECASS III trial arms using PSM method at a 1:1:1 ratio. The proportin of favourable outcome was 63.3% in this trial, as compared with 61.7% in the matched ECASS III trial alteplase arm (OR 1.07, 95% CI 0.64 to 1.81) and 56.7% in the matched placebo arm (OR 1.32, 95% CI 0.79 to 2.22). ECASS III, European Cooperative Acute Stroke Study III; mRS,modified Rankin Scale; PSM, propensity score matching. * indicates the number of patients was based on Propensity Score Matching (PSM) method .
Tables
- Table 1
Demographic and baseline characteristics
Present trial ECASS III trial Alteplase arm
(n=120)Alteplase arm
(n=120*)Placebo arm
(n=120*)Age ±SD, years 61.1±10.8 61.4±13.4 62.2±13.0 Male, % 80.0 80.8 71.7 Weight±SD, kg 67.2±13 70.8±13 71.4±11 NIHSS score Mean±SD 6.9±4.7 7.9±3.6 8.3±4.3 Median (IQR) 6.0 (3.0–9.0) 7.0 (6.0–10.0) 7.0 (5.0–10.0) Systolic blood pressure ±SD, mm Hg 152.0±18.7 153.2±17.8 151.6±22.0 Diastolic blood pressure ±SD, mm Hg 88.5±12.5 87.8±11.2 85.6±14.6 Diabetes, % 17.5 16.7 15.0 Hypertension, % 52.5 54.2 47.5 Atrial flutter or fibrillation, % 15.0 13.3 15.8 History of stroke, % 10.8 8.3 10.0 Prior use of antithrombotic, N (%) 2 (1.7) – – Time from onset to needle Median (IQR) 3 hours 54 min
(3 hours 32 min–
4 hours 10 min)3 hours 56 min
(3 hours 43 min–
4 hours 15 min)3 hours 54 min
(3 hours 40 min–4 hours 12 min)By 0.5 hours period, % ≥3.0 to ≤3.5 hours 21.7 15.8 15.8 >3.5 to ≤4.0 hours 39.2 45.0 49.2 >4.0 to ≤4.5 hours 39.2 39.2 35.0 *The number of patients was based on Propensity Score Matching method at a 1:1:1 ratio, 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.
ECASS III, European Cooperative Acute Stroke Study III; NIHSS, National Institutes of Health Stroke Scale.
- Table 2
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.
- Table 3
Overall summary of AEs
Endpoints
N (%)Present trial
(treated population)ECASS III
(intention-to-treat population)Alteplase arm
(n=120)Alteplase arm
(n=120*)Placebo arm
(n=120*)Drug-related AEs 15 (12.5) – – SAEs 23 (19.2) – – ICH 10 (8.3) – – sICH† 3 (2.5)‡ 2 (1.7) 0 (0.0) Death within 3 months 6 (5.0) 7 (5.8) 7 (5.8) Death within overall period 7 (5.8) 8 (6.7) 7 (5.8) Symptomatic oedema 3 (2.5) – – Cerebral herniation 2 (1.7) – – *The number of patients was based on Propensity Score Matching (PSM) method.
† sICH defined according to ECASS III criteria.
‡Exact 95% CI 0.5 to 7.1; 95% Wilson Score 95% CI 0.9 to 7.1.
AE, adverse event; ECASS III, European Cooperative Acute Stroke Study III; SAE, serious adverse event; sICH, symptomatic intracranial haemorrhage.
- Table 4
SAEs within 3 months by system organ class
Present trial
(n=120)No of patients with SAEs 23 (19.2) SAEs by system organ class Cardiac disorders 1 (0.8) Eye disorders 1 (0.8) Gastrointestinal disorders 1 (0.8) Hepatobiliary disorders 2 (1.7) Infections and infestations 4 (3.3) Injury, poisoning and procedural complications 2 (1.7) Musculoskeletal and connective tissue disorders 1 (0.8) Neoplasms benign, malignant and unspecified (including cysts and polyps) 1 (0.8) Nervous system disorders 11 (9.2) Respiratory, thoracic and mediastinal disorders 3 (2.5) SAE, serious adverse event.
Supplementary data
Supplementary data
Supplementary data
