Table 1. Baseline Characteristics for the As-Treated Study Population by Major Hemorrhage Status.
| Characteristica | No. | Major Hemorrhage (n = 27) | No. | No Major Hemorrhage (n = 4792) | P Value |
|---|---|---|---|---|---|
| Age, median (IQR), y | 27 | 74.0 (60.0-84.0) | 4792 | 65.0 (55.0-74.0) | .004 |
| Female sex, No. (%) | 27 | 15 (55.6) | 4792 | 2151 (44.9) | .27 |
| Race, No. (%) | |||||
| White | 26 | 19 (73.1) | 4655 | 3489 (75.0) | .47 |
| Black | 5 (19.2) | 953 (20.5) | |||
| Asian | 1 (3.9) | 142 (3.1) | |||
| Other | 1 (3.9) | 26 (0.6) | |||
| Ethnicity, No. (%) | |||||
| US, non-Hispanic | 26 | 24 (92.3) | 4564 | 4280 (93.8) | .68 |
| US, Hispanic | 2 (7.7) | 284 (6.2) | |||
| Region, No. (%) | |||||
| United States | 27 | 23 (85.2) | 4792 | 3965 (82.7) | >.99 |
| Outside United States | 4 (14.8) | 827 (17.3) | |||
| Blood pressure, median (IQR), mm Hg | |||||
| Systolic | 27 | 163.0 (142.0-181.0) | 4788 | 159.0 (143.0-180.0) | .56 |
| Diastolic | 27 | 85.0 (68.0-98.0) | 4788 | 87.0 (77.0-98.0) | .20 |
| Medical history, No. (%) | |||||
| Congestive heart failure | 27 | 0 (0.0) | 4785 | 122 (2.6) | >.99 |
| Atrial fibrillation | 27 | 1 (3.7) | 4778 | 47 (1.0) | .24 |
| Ischemic heart disease | 27 | 3 (11.1) | 4780 | 487 (10.2) | .75 |
| Hypertension | 26 | 22 (84.6) | 4772 | 3305 (69.3) | .13 |
| Diabetes | 27 | 8 (29.6) | 4845 | 1332 (27.5) | .80 |
| Current tobacco smoker, No. (%) | 27 | 6 (22.2) | 4789 | 987 (20.6) | .84 |
| Taking aspirin at presentation, No. (%) | 27 | 15 (55.6) | 4792 | 2761 (57.6) | .83 |
| Taking clopidogrel at presentation, No. (%) | 27 | 1 (3.7) | 4791 | 87 (1.8) | .40 |
| Prior use of PPIs, No. (%) | 27 | 10(37.0) | 4792 | 610 (12.7) | .001 |
| Time to randomization, mean (SD), h | 27 | 7.7 (3.2) | 4792 | 7.3 (2.9) | .50 |
| Time to randomization, No. (%), h | |||||
| <6 | 27 | 8 (29.6) | 4792 | 1520 (31.7) | .82 |
| >6 | 19 (70.4) | 3272 (68.3) | |||
| Qualifying event, No. (%) | |||||
| TIA | 27 | 15 (55.6) | 4792 | 2066 (43.1) | .20 |
| Ischemic stroke | 12 (44.4) | 2726 (56.9) | |||
| Qualifying TIA baseline ABCD2 score, median (IQR) | 15 | 5.0 (5.0-6.0) | 2062 | 5.0 (4.0-6.0) | .24 |
| Qualifying ischemic stroke baseline NIHSS score, median (IQR) | 12 | 2.0 (1.0-2.5) | 2703 | 2.0 (1.0-2.0) | .79 |
Abbreviations: ABCD2, age/blood pressure/clinical features/duration of symptoms/diabetes; IQR, interquartile range; NIHSS, National Institutes of Health Stroke Scale; PPI, proton pump inhibitors; TIA, transient ischemic attack.
a
Differences in baseline characteristics between treatment groups were not significant with exception of age (P = .004) and prior use of PPIs (P = .001). Race was missing/unknown for 138 participants; ethnicity was missing/unknown for 229 participants. The ABCD2 score was given only for TIA group (n = 2081 with 4 missing). The NIHSS score was given only for ischemic stroke group (n = 2738 with 23 missing).