Table 3. Cognitive and Mood Outcomes at 12 Months.
| Outcome | All patients (n = 358), No. (%) | ISMN | Cilostazol | ISMN-cilostazol | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| With (n = 178) | Without (n = 180) | aOR, aHR, or aMD (95% CI) | P value | With (n = 178) | Without (n = 180) | aOR, aHR, aMD (95% CI) | P value | With (n = 89) | Without (n = 91) | aOR, aHR, or aMD (95% CI) | P value | ||
| Ordinal 7-level cognition, No. (%) (n = 308)a | |||||||||||||
| Normal | 124 (40.3) | 68 (45.6) | 56 (35.2) | 0.55 (0.36 to 0.86) | 0.008 | 68 (44.4) | 56 (36.1) | 0.88 (0.57 to 1.37) | 0.58 | 40 (53.3) | 28 (34.6) | 0.44 (0.23 to 0.85) | 0.02 |
| Minor | |||||||||||||
| Single domain | 82 (26.6) | 43 (28.9) | 39 (24.5) | 33 (21.6) | 49 (31.6) | 14 (18.7) | 20 (24.7) | ||||||
| Multidomain | 34 (11.0) | 14 (9.4) | 20 (12.6) | 17 (11.1) | 17 (11.0) | 9 (12.0) | 12 (14.8) | ||||||
| Major | |||||||||||||
| Mild | 56 (18.2) | 20 (13.4) | 36 (22.6) | 29 (19.0) | 27 (17.4) | 11 (14.7) | 18 (22.2) | ||||||
| Moderate | 7 (2.3) | 2 (1.3) | 5 (3.1) | 3 (2.0) | 4 (2.6) | 0 | 2 (2.5) | ||||||
| Severe | 1 (0.3) | 1 (0.7) | 0 | 1 (0.7) | 0 | 1 (1.3) | 0 | ||||||
| Died | 4 (1.3) | 1 (0.7) | 3 (1.9) | 2 (1.3) | 2 (1.3) | 0 | 1 (1.2) | ||||||
| Individual cognition, mean (SD) | |||||||||||||
| tMoCA score out of 22 (n = 307)b | 18.4 (3.5) | 18.8 (3.1) | 18.0 (3.9) | 0.62 (−0.12 to 1.36) | 0.10 | 18.6 (3.6) | 18.1 (3.5) | 0.37 (−0.37 to 1.11) | 0.33 | 19.3 (2.6) | 18.0 (3.6) | 1.14 (0.24 to 2.04) | 0.01 |
| Verbal fluency (animal naming) (n = 319)b | 19.5 (7.3) | 20.0 (7.4) | 19.0 (7.2) | 0.75 (−0.74 to 2.25) | 0.32 | 19.8 (7.7) | 19.2 (6.9) | 0.56 (−0.93 to 2.05) | 0.46 | 19.8 (7.3) | 18.2 (6.1) | 1.21 (−0.65 to 3.06) | 0.20 |
| Trail Making Test Part B score (n = 156) | |||||||||||||
| Time, sb | 123.0 (64.9) | 114.9 (57.2) | 131.2 (71.3) | −13.39 (−32.00 to 5.21) | 0.16 | 120.5 (57.2) | 125.5 (72.2) | −2.98 (−21.45 to 15.50) | 0.75 | 112.1 (48.0) | 134.0 (78.8) | −22.36 (−47.56 to 2.84) | 0.08 |
| Pointsb | 22.8 (5.3) | 22.4 (5.7) | 23.2 (5.0) | −1.00 (−2.65 to 0.65) | 0.23 | 22.3 (6.5) | 23.3 (3.8) | −0.86 (−2.50 to 0.78) | 0.30 | 21.9 (6.6) | 23.9 (2.6) | −1.62 (−3.75 to 0.51) | 0.14 |
| Mood, mean (SD) | |||||||||||||
| Zung depression scale score out of 102.5 (n = 317)b | 50.0 (17.3) | 48.5 (16.3) | 51.3 (18.1) | −2.23 (−5.70 to 1.24) | 0.21 | 48.4 (16.8) | 51.4 (17.7) | −3.34 (−6.81 to 0.14) | 0.06 | 47.6 (15.9) | 53.2 (18.4) | −5.98 (−10.77 to −1.20) | 0.01 |
Abbreviations: aHR, adjusted hazard ratio; aMD, adjusted mean difference; aOR, adjusted odds ratio; MLR, multiple linear regression; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale; OLR, ordinal logistic regression; tMoCA, telephone Montreal Cognitive Assessment.
Analyses were performed using OLR with output as aMD; all adjusted for age, sex, time from stroke onset to randomization, years of education, smoking status, baseline mRS (dependence), stroke severity (NIHSS), systolic blood pressure, and baseline tMoCA.
Analyses were performed using MLR with output as aMD; all were adjusted as for OLR. For ordinal scales with more than 7 levels (central limit theorem/large sample), the mean (SD) and MLR were used instead of the median (IQR) and OLR.