Table 2.
Primary and secondary outcomes.
| N | Metoclopramide |
Ceftriaxone |
Paracetamol |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yes | None | DIM/OR (95% CI) | p | Yes | None | DIM/OR (95% CI) | p | Yes | None | DIM/OR (95% CI) | p | ||
| Primary outcomea | |||||||||||||
| mRS, median [IQR] | 1471 | 4 [2,5] | 4 [2,5] | 1.01 (0.81, 1.25) | 0.94 | 4 [2,5] | 4 [2,5] | 0.99 (0.77, 1.27) | 0.92 | 4 [2,5] | 4 [2,5] | 1.19 (0.96, 1.47) | 0.12 |
| Sensitivity analysis | |||||||||||||
| mRS, unadjusted | 1471 | 4 [2,5] | 4 [2,5] | 0.97 (0.80, 1.16) | 0.73 | 4 [2,5] | 4 [2,5] | 1.00 (0.81, 1.24) | 0.97 | 4 [2,5] | 4 [2,5] | 1.08 (0.90, 1.29) | 0.42 |
| mRS, imputed | 1492 | 4 [2,5] | 4 [2,5] | 1.00 (0.81, 1.25) | 0.98 | 4 [2,5] | 4 [2,5] | 0.99 (0.77, 1.28) | 0.96 | 4 [2,5] | 4 [2,5] | 1.19 (0.97, 1.48) | 0.10 |
| mRS, mean | 1471 | 3.6 (1.8) | 3.6 (1.8) | −0.02 (−0.21, 0.16) | 0.83 | 3.6 (1.9) | 3.7 (1.8) | −0.06 (−0.27, 0.15) | 0.59 | 3.7 (1.8) | 3.6 (1.9) | 0.13 (−0.05, 0.32) | 0.15 |
| mRS > 2 (%) | 1471 | 495 (71.4) | 513 (73.4) | 0.84 (0.62, 1.14) | 0.27 | 423 (72.2) | 355 (74.4) | 0.91 (0.64, 1.29) | 0.58 | 517 (73.8) | 518 (71.7) | 1.15 (0.85, 1.55) | 0.35 |
| By diagnosis | |||||||||||||
| Ischaemic stroke | 1250 | 4 [2,5] | 4 [2,5] | 1.00 (0.80, 1.25) | 1.00 | 4 [2,5] | 4 [2,5] | 0.97 (0.75, 1.24) | 0.78 | 4 [2,5] | 4 [2,5] | 1.18 (0.95, 1.47) | 0.13 |
| Intracerebral haemorrhage | 201 | 4 [3,5] | 4 [3,5] | 0.92 (0.53, 1.62) | 0.78 | 4 [3,5] | 4 [3,5] | 1.09 (0.53, 2.25) | 0.81 | 4 [3,5] | 4 [3,5] | 0.82 (0.47, 1.43) | 0.49 |
| Other diagnosis | 20 | 2 [2,3] | 2.5 [1.5, 3.5] | 31.53 (0.01, 78,349) | 0.39 | 3 [2,6] | 2.5 [2, 3.5] | 3 [2,6] | 2 [2,3] | 1707.8 (0.34, 8.59E6) | 0.087 | ||
| Secondary outcomes | |||||||||||||
| Death (%) | 1471 | 152 (21.9) | 154 (22) | 1.04 (0.80, 1.36) | 0.76 | 134 (22.9) | 108 (22.6) | 1.06 (0.78, 1.43) | 0.71 | 157 (22.4) | 159 (22) | 1.13 (0.87, 1.46) | 0.36 |
| Patient location | 1.05 (0.83, 1.33) | 0.67 | 1.02 (0.78, 1.34) | 0.89 | 1.32 (1.05, 1.66) | 0.018 | |||||||
| Home (%) | 1464 | 276 (39.9) | 289 (41.6) | 220 (38.1) | 178 (37.7) | 267 (38.6) | 315 (43.5) | ||||||
| Nursing home (%) | 1464 | 53 (7.7) | 52 (7.5) | 45 (7.8) | 35 (7.4) | 52 (7.5) | 59 (8.1) | ||||||
| Rehabilitation service (%) | 1464 | 128 (18.5) | 137 (19.7) | 126 (21.8) | 104 (22) | 137 (19.8) | 127 (17.5) | ||||||
| Hospital (%) | 1464 | 72 (10.4) | 59 (8.5) | 47 (8.1) | 43 (9.1) | 72 (10.4) | 58 (8) | ||||||
| Other (%) | 1464 | 10 (1.4) | 4 (0.6) | 6 (1) | 4 (0.8) | 7 (1) | 6 (0.8) | ||||||
| Died (%) | 1464 | 152 (22) | 154 (22.2) | 134 (23.2) | 108 (22.9) | 157 (22.7) | 159 (22) | ||||||
| Home time (No of days) | 1465 | 27.7 (39.5) | 31.2 (47.6) | −3.02 (−8.18, 2.14) | 0.25 | 28 (41.9) | 26.3 (44) | 1.55 (−4.31, 7.40) | 0.60 | 28.6 (47.8) | 30.9 (39.6) | −2.91 (−7.96, 2.14) | 0.26 |
| Questionnaires | |||||||||||||
| Barthel index | 1383 | 50.3 (43.6) | 48.2 (42.8) | 1.24 (−3.15, 5.62) | 0.58 | 48.4 (43.5) | 48.4 (43) | 1.29 (−3.70, 6.28) | 0.61 | 48.1 (43.1) | 49.5 (43.4) | −1.81 (−6.11, 2.49) | 0.41 |
| MoCA | 722∗ | 11.8 (12.1) | 11.1 (12.1) | 0.30 (−1.30, 1.90) | 0.71 | 12 (12.5) | 11.1 (12.1) | −0.12 (−1.89, 1.65) | 0.89 | 11 (12) | 11.5 (12.1) | −0.43 (−1.98, 1.13) | 0.59 |
| MOCA, alive only | 397∗ | 21.3 (6.6) | 21.5 (5.9) | 0.05 (−1.17, 1.28) | 0.93 | 22.3 (6.1) | 21.8 (5.7) | 0.04 (−1.26, 1.34) | 0.96 | 21 (6.5) | 21.6 (6) | −0.26 (−1.48, 0.96) | 0.68 |
| EQ-5D-5L | 1098 | 0.5 (0.4) | 0.5 (0.4) | 0.00 (−0.04, 0.05) | 0.89 | 0.5 (0.4) | 0.5 (0.4) | 0.02 (−0.04, 0.07) | 0.53 | 0.5 (0.4) | 0.5 (0.4) | −0.03 (−0.07, 0.02) | 0.24 |
| EQ-VAS | 1071 | 43.7 (34.5) | 42.7 (34.5) | −0.14 (−4.19, 3.92) | 0.95 | 41.1 (34.2) | 41.7 (34.9) | −0.14 (−4.78, 4.50) | 0.95 | 41.7 (34.4) | 43.8 (34.7) | −2.26 (−6.23, 1.71) | 0.27 |
Data are n (%), median [IQR], or mean (SD). Treatments effects are adjusted for stratification (country), minimisation (age, sex, stroke type, stroke severity, diabetes), and other baseline prognostic factors (e.g. pre-morbid mRS, atrial fibrillation, reperfusion treatment [alteplase and/or thrombectomy], time from onset to randomisation), and treatment allocation to the other two strata of the trial, unless otherwise stated. aDIM: adjusted difference in means. aHR: adjusted hazards ratio. aOR: adjusted odds ratio. Comparison by adjusted ordinal logistic regression (aOLR), multiple linear regression (aMLR), Cox proportional hazards regression (CPHR) or adjusted binary logistic regression (aBLR). mRS, modified Rankin Scale; MoCA, Montreal Cognitive Assessment; EQ-5D-5L, EuroQol 5D-5L; EQ-VAS, EuroQol-Visual Analogue Scale. Scores for death are included in questionnaire outcomes as follows: mRS, 6; Barthel Index, −5; EQ-5D-5L, 0; EQ-VAS, −1; MOCA, −1. ∗: During the COVID-19 pandemic, in-person visits were substituted by virtual visits for many patients, preventing assessment of the MoCA.
Likelihood ratio test: for metoclopramide vs. no metoclopramide, p = 0.83; ceftriaxone vs. no ceftriaxone, p = 0.23; paracetamol vs. no paracetamol, p = 0.94.