Table 1.
Baseline characteristics of the patients aged ≥65 years versus <65 years, stratified according to treatment arm.
| Characteristic | Age <65 y | Age ≥65 y | ||||
|---|---|---|---|---|---|---|
| Clopidogrel plus aspirin (N = 655) | Aspirin alone (N = 594) | p-value | Clopidogrel plus aspirin (N = 815) | Aspirin alone (N = 767) | p-value | |
| Female | 179/655 (27.33) | 176/594 (29.63) | 0.368 | 339/815 (41.6) | 301/767 (39.24) | 0.340 |
| BMI | 23.94 (22.31 ~ 25.53) | 24.21 (22.31 ~ 25.81) | 0.311 | 23.44 (21.97 ~ 25.06) | 23.44 (21.72 ~ 25.39) | 0.487 |
| Current smoking | 260/647 (40.19) | 241/589 (40.92) | 0.794 | 228/811 (28.11) | 196/762 (25.72) | 0.285 |
| Current alcohol consumption | 161/647 (24.88) | 150/589 (25.47) | 0.814 | 129/810 (15.93) | 118/761 (15.51) | 0.819 |
| Comorbidities | ||||||
| Hypertension | 404/655 (61.68) | 365/594 (61.45) | 0.933 | 505/815 (61.96) | 480/767 (62.58) | 0.800 |
| Diabetes | 184/655 (28.09) | 153/594 (25.76) | 0.353 | 205/815 (25.15) | 173/767 (22.56) | 0.226 |
| Previous ischemic stroke | 185/647 (28.59) | 174/590 (29.49) | 0.728 | 283/812 (34.85) | 266/767 (34.68) | 0.943 |
| Myocardial infarction | 64/643 (9.95) | 57/587 (9.71) | 0.886 | 174/812 (21.43) | 135/764 (17.67) | 0.060 |
| Atrial fibrillation | 1/644 (0.16) | 1/584 (0.17) | 0.945 | 15/810 (1.85) | 13/763 (1.7) | 0.824 |
| Hyperlipidemia | 7/633 (1.11) | 9/576 (1.56) | 0.488 | 10/799 (1.25) | 7/761 (0.92) | 0.528 |
| Previous TIA | 4/652 (0.61) | 1/586 (0.18) | 0.220 | 2/810 (0.25) | 2/764 (0.26) | 0.953 |
| OTT, hours | 17 (8.23 ~ 26) | 19.47 (8.5 ~ 26) | 0.689 | 15.48 (6.75 ~ 26) | 14.5 (7 ~ 26) | 0.314 |
| <24 h | 390/655 (59.54) | 346/594 (58.25) | 0.643 | 489/815 (60) | 473/767 (61.67) | 0.497 |
| ≥24 h | 265/655 (40.46) | 248/594 (41.75) | 326/815 (40) | 294/767 (38.33) | ||
| NIHSS score at randomization | ||||||
| Median (IQR) | 4 (4 ~ 6) | 4 (4 ~ 6) | 0.948 | 5 (4 ~ 6) | 5 (4 ~ 6) | 0.775 |
| <7 | 585/655 (89.31) | 532/594 (89.56) | 0.886 | 720/815 (88.34) | 683/767 (89.05) | 0.658 |
| ≥7 | 70/655 (10.69) | 62/594 (10.44) | 95/815 (11.66) | 84/767 (10.95) | ||
| Estimated premorbid function (mRS score) | ||||||
| 0 | 462/655 (70.53) | 427/594 (71.89) | 0.599 | 573/815 (70.31) | 551/767 (71.84) | 0.711 |
| 1 | 193/655 (29.47) | 167/594 (28.11) | 240/815 (29.45) | 215/767 (28.03) | ||
| 2 | 0 | 0 | 2/815 (0.25) | 1/767 (0.13) | ||
| Presumed stroke cause | ||||||
| Large artery atherosclerosis | 55/653 (8.42) | 38/593 (6.41) | 0.410 | 57/814 (7) | 55/766 (7.18) | 0.846 |
| Cardioembolic | 0 | 0 | 0 | 1/766 (0.13) | ||
| Small artery occlusion | 191/653 (29.25) | 189/593 (31.87) | 248/814 (30.47) | 240/766 (31.33) | ||
| Other determined cause | 4/653 (0.61) | 2/593 (0.34) | 3/814 (0.37) | 2/766 (0.26) | ||
| Undetermined | 403/653 (61.72) | 364/593 (61.38) | 506/814 (62.16) | 468/766 (61.1) | ||
| Location of the responsible vessel (identified by circulation infarction) | ||||||
| Anterior | 386/571 (67.6) | 360/495 (72.73) | 0.146 | 504/714 (70.59) | 473/648 (72.99) | 0.270 |
| Posterior | 169/571 (29.6) | 120/495 (24.24) | 190/714 (26.61) | 151/648 (23.3) | ||
| Anterior and posterior | 16/571 (2.8) | 15/495 (3.03) | 20/714 (2.8) | 24/648 (3.7) | ||
| Time to hospital discharge, days | 12 (10 ~ 14) | 12 (10 ~ 14) | 0.429 | 11 (10 ~ 13) | 11 (9 ~ 13) | 0.078 |
Data are shown as % (n/N) or median (IQR). BMI, indicates body mass index; TIA, transient ischemic attack; OTT, time from stroke onset to antiplatelet therapy; NIHSS, National Institutes of Health Stroke Scale; mRS, modified Rankin Scale. The presumed stroke cause was classified according to the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) criteria, based on clinical findings, brain imaging, and laboratory tests. Scores on the modified Rankin Scale (mRS) for functional disability range from 0 (no symptoms) to 6 (death). A score of 0 indicates no symptoms, one indicates symptoms without disability, and two indicates mild disability.