Table 1.
Characteristics of the Patients at Baseline.*
| Characteristic | Clopidogrel plus Aspirin (N = 2432) | Aspirin (N = 2449) |
|---|---|---|
| Median age (IQR) — yr | 65.0 (55.0–74.0) | 65.0 (56.0–74.0) |
| Female sex — no. (%) | 1097 (45.1) | 1098 (44.8) |
| Race — no./total no. (%)† | ||
| White | 1774/2360 (75.2) | 1781/2378 (74.9) |
| Black | 473/2360 (20.0) | 493/2378 (20.7) |
| Asian | 77/2360 (3.3) | 67/2378 (2.8) |
| Other | 36/2360 (1.5) | 37/2378 (1.6) |
| Hispanic ethnic group — no./total no. (%)† | 144/2320 (6.2) | 146/2328 (6.3) |
| Region — no. (%) | ||
| United States | 2014 (82.8) | 2029 (82.9) |
| Other countries | 418 (17.2) | 420 (17.1) |
| Medical history — no./total no. (%) | ||
| Ischemic heart disease | 257/2426 (10.6) | 240/2443 (9.8) |
| Hypertension | 1693/2423 (69.9) | 1680/2437 (68.9) |
| Diabetes mellitus | 678/2425 (28.0) | 662/2447 (27.1) |
| Medication use at presentation — no. (%) | ||
| Aspirin | 1417 (58.3) | 1397 (57.0) |
| Clopidogrel | 48 (2.0) | 42 (1.7) |
| Time from presentation to randomization | ||
| Mean time (±SD) — hr | 7.4±3.0 | 7.3±2.9 |
| Interval — no./total no. (%) | ||
| <6 hr | 755/2431 (31.1) | 789/2449 (32.2) |
| ≥6 hr | 1676/2431 (68.9) | 1660/2449 (67.8) |
| Qualifying event — no. (%) | ||
| TIA | 1056 (43.4) | 1052 (43.0) |
| Ischemic stroke | 1376 (56.6) | 1397 (57.0) |
| Median qualifying neurologic score (IQR) | ||
| ABCD2 for TIA‡ | 5.0 (4.0–6.0) | 5.0 (4.0–5.0) |
| NIHSS for ischemic stroke§ | 2.0 (1.0–2.0) | 2.0 (1.0–2.0) |
There were no significant differences in baseline characteristics between the two groups. IQR denotes interquartile range, and TIA transient ischemic attack.
Race or ethnic group was determined by the investigator. Hispanic ethnic group was assessed only in patients in the United States; the denominator excludes 233 patients for whom Hispanic status was unknown.
Among patients with TIA, the qualifying score was 4 or more on the ABCD2 scale, which ranges from 0 to 7, with higher scores indicating a greater risk of stroke. The scale is used to estimate the risk of recurrent stroke after a TIA on the basis of age, blood pressure, clinical features, duration of symptoms, and presence of diabetes. Scores were available for 2104 of the 2108 patients with TIA (1055 patients in the clopidogrel group and 1049 in the aspirin group).
A mong patients with ischemic stroke, the qualifying score was 3 or less on the National Institutes of Health Stroke Scale (NIHSS), which ranges from 0 to 42, with higher scores indicating a greater stroke severity. Scores were available for 2750 of the 2773 patients with ischemic stroke (1365 patients in the clopidogrel group and 1385 in the aspirin group).