Primary and secondary outcomes in ITT and per-protocol populations
| ITT | Per protocol | |||
|---|---|---|---|---|
| mRS 0–2 at day 90 | OR 2.12 (0.65 to 6.94) | p=0.204 | OR 4.92 (1.23 to 19.69) | p=0.021 |
| Secondary outcomes | ||||
| mRS 0–1 at day 90 | OR 7.63 (1.56 to 37.22) | p=0.010 | OR 14.6 (2.11 to 101.5) | p=0.005 |
| mRS distribution | OR 2.59 (0.93 to 7.24)* | p=0.070 | OR 4.47 (1.45 to 13.80)* | p=0.009 |
| Death | OR 1.56 (0.29 to 8.40) | p=0.599 | OR 0.69 (0.10 to 4.68) | p=0.697 |
| Early major neurological improvement (NIHSS 0–1 or improved ≥8) | OR 1.83 (0.54 to 6.25) | p=0.321 | OR 2.98 (0.76 to 11.65) | p=0.106 |
| Days in usual residence, days 0–90 | 68 vs 78.5 | p=0.782† | 58 vs 79 | p=0.411† |
| SICH (SITS-MOST) | 0 vs 0 | p=1.000‡ | 0 vs 0 | p=1.000‡ |
| PH1/2 ICH | 1 vs 3 | p=0.613‡ | 0 vs 3 | p=0.238‡ |
| IST-3 angiographic score=4 at 24 hours | OR 0.18 (0.05 to 0.64) | p=0.008 | OR 0.17 (0.04 to 0.64) | p=0.009 |
*Adjusted for baseline (prestroke) mRS in addition to minimisation variables.
†p value from exact permutation test.
‡p value from exact Fisher test.
ITT, intention to treat; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; SICH, symptomatic intracerebral haemorrhage.