Table 1. Baseline Patient Characteristics.
| Characteristics | Intravenous Alteplase + Oral Placebo (n=156) | Intravenous Placebo + Oral Aspirin (nā=ā157) |
|---|---|---|
| Age, mean (SD), y | 62 (14) | 61 (13) |
| Male sex, No. (%) | 77 (49) | 92 (59) |
| Race, No. (%)a | ||
| White | 117 (75.0) | 126 (80.3) |
| Black/African American | 35 (22.4) | 27 (17.2) |
| American Indian or Alaska Native | 1 (0.6) | 3 (1.9) |
| Asian | 0 | 1 (0.6) |
| ā„2 races | 1 (0.6) | 0 |
| Unknown | 2 (1.3) | 0 |
| Hispanic or Latino ethnicity, No. (%)a | 14 (9.0) | 18 (11.5) |
| Medical history, No. (%) | ||
| Hypertension | 126 (81.3) | 124 (79.0) |
| Hyperlipidemia | 114 (73.1) | 114 (72.6) |
| Diabetes mellitus | 57 (36.5) | 44 (28.0) |
| Previous stroke | 28 (17.9) | 24 (15.3) |
| Atrial fibrillation | 23 (14.7) | 17 (10.8) |
| Medications prior to onset, No. (%) | ||
| Antiplatelet agents | 64 (41.0) | 59 (37.6) |
| Anticoagulant agents | 1 (0.6) | 1 (0.6) |
| Time from symptom onset to intravenous study treatment bolus, h | ||
| No. (%) | ||
| 0 to 2 | 25 (16.0) | 36 (22.9) |
| >2 to 3 | 126 (80.8) | 119 (75.8) |
| >3b | 5 (3.2) | 2 (1.3) |
| Median (IQR) | 2.7 (2.2-2.9) | 2.6 (2.1-2.9) |
| Time from onset to oral study treatment, median (IQR), h | 2.9 (2.5-3.1) | 2.8 (2.4-3.1) |
| Baseline NIHSS scorec | ||
| No. (%) | ||
| 0 | 7 (4.5) | 7 (4.5) |
| 1 | 38 (24.4) | 50 (31.8) |
| 2 | 52 (33.3) | 50 (31.8) |
| 3 | 32 (20.5) | 30 (19.1) |
| 4 | 21 (13.5) | 16 (10.2) |
| 5 | 6 (3.8) | 4 (2.5) |
| Mean (SD) | 2.3 (1.2) | 2.0 (1.2) |
| Glucose level, mean (SD), mg/dL | 141.2 (72.9) | 132.1 (61.8) |
| Systolic blood pressure >140 mm Hg, No. (%) | 83 (53.2) | 112 (71.3) |
| Diastolic blood pressure >90 mm Hg, No. (%) | 31 (19.9) | 44 (28.0) |
| Baseline international normalized ratio >1.1, No. (%) | 42 (26.9) | 52 (33.1) |
| Baseline ASPECTS, median (range)d | 10 (7-10) | 10 (7-10) |
Abbreviation: IQR, interquartile range.
SI conversion: To convert glucose to mmol/L, multiply by 0.0555.
Race and ethnicity were self-reported as categories of Hispanic/Latino (yes/no) and either American Indian or Alaska Native, Asian, black or African American, Native Hawaiian or other Pacific Islander, white, or other.
Six of the 7 patients received the study bolus within 3 hours and 15 minutes.
The National Institutes of Health Stroke Scale (NIHSS) score classifies neurologic deficit from 0 (no deficit) to 42 (most severe).
Alberta Stroke Program Early Computed Tomography Score (ASPECTS) semiquantitatively measures the extent of acute early ischemic changes in the middle cerebral artery distribution on a computed tomography scan, with a score range of 0 (maximum changes) to 10 (no ischemic changes).