Baseline characteristics in the modified intention-to-treat population
| GD-11 160 mg (n=80) | GD-11 80 mg (n=79) | Placebo (n=80) | P value | |
| Age (years) | ||||
| Median (IQR) | 64 (58.5–71) | 65(58–70) | 65(58–72) | 0.7552 |
| <65 | 41 (51.3%) | 39 (49.4%) | 36 (45.0%) | 0.7196 |
| ≥65 | 39 (48.8%) | 40 (50.6%) | 44 (55.0%) | |
| Sex | ||||
| Female | 62 (77.5%) | 57 (72.2%) | 56 (70.0%) | 0.5443 |
| Male | 18 (22.5%) | 22 (27.8%) | 24 (30.0%) | |
| NIHSS score | ||||
| Median (IQR) | 7 (6–8) | 7 (6–8) | 7 (6–8) | 0.7005 |
| Previous mRS | ||||
| 0 | 73 (91.3%) | 69 (87.3%) | 76 (95.0%) | 0.2335 |
| 1 | 7 (8.8%) | 10 (12.7%) | 4 (5.0%) | |
| Weight (kg) | ||||
| Median (IQR) | 68.25 (62–75) | 65 (60–72.5) | 68 (60–75) | 0.4271 |
| Systolic pressure (mm Hg) | ||||
| Mean (SD) | 142.06±16.76 | 147.78±20.53 | 144.75±16.61 | 0.1376 |
| Diastolic pressure (mm Hg) | ||||
| Mean (SD) | 84.59±10.41 | 87.66±12.68 | 84.95±10.99 | 0.1810 |
| Smoking status | ||||
| Past | 6 (7.5%) | 5 (6.3%) | 8 (10.0%) | 0.3648 |
| No | 47 (58.8%) | 54 (68.4%) | 42 (52.5%) | |
| Current | 27 (33.8%) | 20 (25.3%) | 30 (37.5%) | |
| Hypertension | 62 (77.5%) | 66 (83.5%) | 63 (78.8%) | 0.6045 |
| Diabetes | 11 (13.8%) | 10 (12.7%) | 12 (15.0%) | 0.9123 |
| Hyperlipidaemia | 28 (35.0%) | 23 (29.1%) | 27 (33.8%) | 0.7067 |
| Previous stroke history | ||||
| Yes | 27 (33.8%) | 26 (32.9%) | 26 (32.5%) | 0.9854 |
| No | 53 (66.3%) | 53 (67.1%) | 54 (67.5%) | |
| rtPA | 8 (10.0%) | 7 (8.86%) | 8 (10.0%) | 0.9613 |
| TOAST | ||||
| LAA | 49 (61.3%) | 47 (59.5%) | 48 (60.0%) | 0.5174 |
| CE | 4 (5.0%) | 6 (7.6%) | 2 (2.5%) | |
| SAO | 22 (27.5%) | 25 (31.6%) | 25 (31.3%) | |
| Other | 5 (6.3%) | 1 (1.3%) | 5 (6.3%) | |
| Time of treatment from onset (hours) | ||||
| Median (IQR) | 28.0 (20–35.6) | 24.0 (18–33.6) | 24.8 (17.7–33.4) | 0.8176 |
| <24 | 39 (48.8%) | 40 (50.6%) | 40 (50.0%) | 0.9712 |
| ≥24 | 41 (51.3%) | 39 (49.4%) | 40 (50.0%) |
CE, cardiogenic embolism; LAA, large artery atherosclerosis; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; rtPA, recombinant tissue plasminogen activator; SAO, small artery occlusion; TOAST, Trail of ORG10172 in Acute Stroke Treatment.