Table 3. Number of Patients With Major Hemorrhage by Subgroup in the As-Treated Study Population.
| Subgroup | Patients, No. (%) | Patients With Event, No. (%) | |
|---|---|---|---|
| Clopidogrel Plus Aspirin | Aspirin | ||
| ABCD2 score | |||
| ≤5 | 1552 (32) | 7 (0.9) | 3 (0.4) |
| >5 | 525 (11) | 4 (1.5) | 1 (0.4) |
| Age, y | |||
| <55 | 1221 (25) | 2 (0.3) | 3 (0.5) |
| 56-65 | 1308 (27) | 3 (0.5) | 0 (0) |
| 66-75 | 1228 (25) | 6 (1.0) | 0 (0) |
| >75 | 1062 (22) | 10 (1.8) | 3 (0.6) |
| Predominant daily aspirin dose, mga | |||
| 0 | 168 (3) | 0 (0.0) | 0 (0) |
| 1-81 | 2989 (62) | 15 (1.0) | 3 (0.2) |
| 82-100 | 421 (9) | 2 (0.9) | 0 (0) |
| >100 | 1122 (23) | 4 (0.7) | 3 (0.5) |
| Baseline carotid stenosis | |||
| No | 4462 (93) | 19 (0.9) | 6 (0.3) |
| Yes | 357 (7) | 2 (1.1) | 0 (0) |
| Baseline NIHSS score | |||
| 0 | 377 (8) | 2 (1.1) | 0 (0) |
| 1 | 909 (19) | 2 (0.5) | 1 (0.2) |
| 2 | 851 (18) | 3 (0.7) | 1 (0.2) |
| 3 | 572 (12) | 3 (1.0) | 0 (0) |
| Country | |||
| Outside United States | 831 (17) | 3 (0.7) | 1 (0.2) |
| United States | 3988 (83) | 18 (0.9) | 5 (0.2) |
| Drug manufacturer | |||
| Sanofi | 3639 (76) | 16 (0.9) | 4 (0.2) |
| Sharp | 1180 (24) | 5 (0.9) | 2 (0.3) |
| Ethnicity | |||
| US, Hispanic | 286 (6) | 2 (1.4) | 0 (0.0) |
| US, non-Hispanic | 3532 (73) | 15 (0.9) | 5 (0.3) |
| Sex | |||
| Male | 2653 (45) | 10 (0.8) | 2 (0.1) |
| Female | 2166 (55) | 11 (1.0) | 4 (0.4) |
| Index event type | |||
| Minor stroke | 2738 (57) | 10 (0.7) | 2 (0.1) |
| TIA | 2081 (43) | 11 (1.1) | 4 (0.4) |
| Medical history | |||
| Hypertension | |||
| No | 1471 (31) | 2 (0.3) | 2 (0.3) |
| Yes | 3327 (69) | 18 (1.1) | 4 (0.2) |
| Prior aspirin use | |||
| No | 2043 (42) | 9 (0.9) | 3 (0.3) |
| Yes | 2776 (58) | 12 (0.9) | 3 (0.2) |
| Prior statin use | |||
| No | 2953 (61) | 11 (0.8) | 3 (0.2) |
| Yes | 1866 (39) | 10 (1.1) | 3 (0.3) |
| New infarct (CT/MRI) | |||
| No | 3417 (71) | 14 (0.8) | 3 (0.2) |
| Yes | 1402 (29) | 7 (1.0) | 3 (0.4) |
| Onset to randomization, h | |||
| <6 | 1528 (32) | 8 (1.1) | 0 (0.0) |
| ≥6 | 3291 (68) | 13 (0.8) | 6 (0.4) |
| Prior medication: PPIs | |||
| No | 4199 (87) | 14 (0.7) | 3 (0.1) |
| Yes | 620 (13) | 7 (2.3) | 3 (0.9) |
| Race | |||
| Asian | 143 (3) | 1 (1.3) | 0 (0.0) |
| Black | 958 (20) | 3 (0.6) | 2 (0.4) |
| Other/unknown | 210 (4) | 1 (1.0) | 1 (1.0) |
| White | 3508 (73) | 16 (0.9) | 3 (0.2) |
| Smoking status | |||
| Current | 993 (21) | 5 (1.0) | 1 (0.2) |
| Never/former | 3823 (79) | 16 (0.8) | 5 (0.3) |
Abbreviations: ABCD2, age/blood pressure/clinical features/duration of symptoms/diabetes; NIHSS, National Institutes of Health Stroke Scale; TIA, transient ischemic attack; CT/MRI, computed tomography/magnetic resonance imaging; PPI, proton pump inhibitor.
a
Predominant daily aspirin dose missing/unknown for 119 patients.