Table 1. Baseline Characteristics by Treatment Allocation to Isosorbide Mononitrate (ISMN), Cilostazol, ISMN-Cilostazol, or No Study Drug.
| Characteristic | All patients (N = 363), No. (%) | ISMN | Cilostazol | All groups | |||||
|---|---|---|---|---|---|---|---|---|---|
| With (n = 181) | Without (n = 182) | With (n = 182) | Without (n = 181) | ISMN-cilostazol (n = 91) | ISMN (n = 90) | Cilostazol (n = 91) | None (n = 91) | ||
| Age, y, median (IQR)a | 64.0 (56.0-72.0) | 64.0 (56.0-72.0) | 64.0 (57.0-73.0) | 63.5 (56.0-72.0) | 65.0 (57.0-72.0) | 63.0 (56.0-72.0) | 65.0 (56.0-72.0) | 64.0 (57.0-73.0) | 64.0 (57.0-74.0) |
| Sex, No. (%) | |||||||||
| Women | 112 (30.9) | 54 (29.8) | 58 (31.9) | 55 (30.2) | 57 (31.5) | 27 (29.7) | 27 (30.0) | 28 (30.8) | 30 (33.0) |
| Men | 251 (69.1) | 127 (70.2) | 124 (68.1) | 127 (69.8) | 124 (68.5) | 64 (70.3) | 63 (70.0) | 63 (69.2) | 61 (67.0) |
| mRS score >1, mean (SD) | 85 (23.4) | 40 (22.1) | 45 (24.7) | 43 (23.6) | 42 (23.2) | 21 (23.1) | 19 (21.1) | 22 (24.2) | 23 (25.3) |
| Onset to randomization, d, median (IQR)a | 79.0 (27.0-244.0) | 83.0 (34.0-251.0) | 76.0 (23.0-244.0) | 83.0 (37.0-238.0) | 75.0 (20.0-251.0) | 100.0 (41.0-252.0) | 74.5 (21.0-251.0) | 75.0 (28.0-238.0) | 77.0 (17.0-256.0) |
| Completed education, y, median (IQR) | 16.0 (15.0-18.0) | 16.0 (15.0-18.0) | 16.0 (15.0-18.0) | 16.0 (15.0-18.0) | 16.0 (15.0-18.0) | 16.0 (15.0-18.0) | 16.0 (15.0-17.0) | 16.0 (15.0-18.0) | 16.0 (15.0-18.0) |
| Current smoker, No. (%) | 67 (18.5) | 34 (18.8) | 33 (18.1) | 34 (18.7) | 33 (18.2) | 18 (19.8) | 16 (17.8) | 16 (17.6) | 17 (18.7) |
| Comorbidity, No. (%) | |||||||||
| Hypertension | 267 (73.6) | 135 (74.6) | 132 (72.5) | 134 (73.6) | 133 (73.5) | 67 (73.6) | 68 (75.6) | 67 (73.6) | 65 (71.4) |
| Hyperlipidemia | 281 (77.4) | 132 (72.9) | 149 (81.9) | 147 (80.8) | 134 (74.0) | 67 (73.6) | 65 (72.2) | 80 (87.9) | 69 (75.8) |
| Diabetes | 80 (22.0) | 38 (21.0) | 42 (23.1) | 40 (22.0) | 40 (22.1) | 18 (19.8) | 20 (22.2) | 22 (24.2) | 20 (22.0) |
| Atrial fibrillation | 5 (1.4) | 3 (1.7) | 2 (1.1) | 1 (0.5) | 4 (2.2) | 1 (1.1) | 2 (2.2) | 0 | 2 (2.2) |
| Carotid stenosis >50% (n = 315) | 9 (2.9) | 6 (2.8) | 3 (1.9) | 3 (2.0) | 6 (3.7) | 2 (2.5) | 4 (5.0) | 1 (1.4) | 2 (2.5) |
| Previous stroke | 25 (6.9) | 9 (5.0) | 16 (8.8) | 14 (7.7) | 11 (6.1) | 5 (5.5) | 4 (4.4) | 9 (9.9) | 7 (7.7) |
| Prior transient ischemic attack | 29 (8.0) | 10 (5.5) | 19 (10.4) | 12 (6.6) | 17 (9.4) | 5 (5.5) | 5 (5.6) | 7 (7.7) | 12 (13.2) |
| Medication use, No. (%) | |||||||||
| Antiplatelets | 352 (97.0) | 176 (97.2) | 176 (96.7) | 177 (97.3) | 175 (96.7) | 88 (96.7) | 88 (97.8) | 89 (97.8) | 87 (95.6) |
| Antihypertensives | 277 (76.3) | 144 (79.6) | 133 (73.1) | 135 (74.2) | 142 (78.5) | 70 (76.9) | 74 (82.2) | 65 (71.4) | 68 (74.7) |
| Statins | 338 (93.1) | 166 (91.7) | 172 (94.5) | 173 (95.1) | 165 (91.2) | 85 (93.4) | 81 (90.0) | 88 (96.7) | 84 (92.3) |
| Blood pressure, mm Hg, median (IQR)a | |||||||||
| Systolic | 143.0 (130-157) | 143.0 (132-157) | 142.0 (128-158) | 142.0 (131-157) | 144.0 (130-158) | 143.0 (133-156) | 144.0 (131-159) | 142.0 (130-159) | 143.0 (126-156) |
| Diastolic | 83.0 (75.0-90.0) | 84.0 (76.0-91.0) | 82.0 (75.0-89.0) | 83.0 (76.0-92.0) | 82.0 (74.0-89.0) | 84.0 (76.0-92.0) | 83.0 (76.0-90.0) | 83.0 (76.0-92.0) | 81.0 (72.0-89.0) |
| Assessment, median (IQR) | |||||||||
| NIHSS score out of 42 | 0 (0-2.0) | 0 (0-2.0) | 0 (0-2.0) | 0 (0-1.0) | 1.0 (0-2.0) | 0 (0-1.0) | 1.0 (0-2.0) | 0 (0-1.0) | 0 (0-2.0) |
| Cognition MoCA score out of a total of 30 (n = 362) | 26.0 (23.0-28.0) | 26.0 (23.0-28.0) | 26.0 (23.0-28.0) | 26.0 (24.0-28.0) | 26.0 (23.0-28.0) | 26.0 (24.0-28.0) | 26.0 (23.0-28.0) | 26.0 (23.0-28.0) | 27.0 (23.0-28.0) |
| Trail Making Test Part B score (n = 359) | |||||||||
| Time, s | 110.0 (75.0-170) | 109.0 (74.0-161.0) | 110.5 (78.0-173.0) | 110.0 (74.0-162.5) | 110.0 (77.0-177.0) | 100.0 (71.0-156.0) | 110.0 (75.0-171.0) | 116.5 (77.0-170.0) | 108.5 (79.0-179.0) |
| Points | 25.0 (23.0-25.0) | 25.0 (23.0-25.0) | 25.0 (23.0-25.0) | 25.0 (23.0-25.0) | 25.0 (23.0-25.0) | 25.0 (23.0-25.0) | 24.0 (23.0-25.0) | 25.0 (22.0-25.0) | 25.0 (23.0-25.0) |
| Imaging results, No. (%) | |||||||||
| Index infarct present | 320 (88.2) | 160 (88.4) | 160 (87.9) | 163 (89.6) | 157 (86.7) | 82 (90.1) | 78 (86.7) | 81 (89.0) | 79 (86.8) |
| Fazekas score of white matter hyperintensity | |||||||||
| 0-2 | 124 (34.2) | 64 (35.4) | 60 (33.0) | 60 (33.0) | 64 (35.4) | 30 (33.0) | 34 (37.8) | 30 (33.0) | 30 (33.0) |
| 3-4 | 143 (39.4) | 73 (40.3) | 70 (38.5) | 76 (41.8) | 67 (37.0) | 41 (45.1) | 32 (35.6) | 35 (38.5) | 35 (38.5) |
| 5-6 | 75 (20.7) | 32 (17.7) | 43 (23.6) | 38 (20.9) | 37 (20.4) | 17 (18.7) | 15 (16.7) | 21 (23.1) | 22 (24.2) |
| Contraindication, No. (%) | |||||||||
| ISMN | 23 (6.3) | 0 | 23 (12.6) | 8 (4.4) | 15 (8.3) | 0 | 0 | 8 (8.8) | 15 (16.5) |
| Cilostazol | 45 (12.4) | 25 (13.8) | 20 (11.0) | 1 (0.5)b | 44 (24.3) | 1 (1.1)b | 24 (26.7) | 0 (0.0) | 20 (22.0) |
Abbreviations: ISMN, isosorbide mononitrate; MoCA, Montreal Cognitive Assessment; mRS, modified Rankin Scale; NIHSS, National Institutes of Health Stroke Scale.
a
Minimization variables included age (≤ vs >70 years), onset to randomization (≤ vs >100 days), highest level of education attained, systolic blood pressure, smoker status, stroke severity (NIHSS), and dependence from the stroke (mRS).
b
One patient initially randomized to ISMN-cilostazol was noted to have an electrocardiogram contraindication to cilostazol (before receiving any drug) and thus only received a prescription for ISMN; this patient was retained in the cilostazol/ISMN-cilostazol groups for intention-to-treat analysis.