Table 1. Baseline Characteristics of the Population in a Study of the Effect of Argatroban Plus Alteplase vs Alteplase on Neurologic Function After Acute Ischemic Stroke.
| Characteristic | No. (%) | |||
|---|---|---|---|---|
| Full analysis set | Randomization set | |||
| Argatroban plus alteplase (n = 364) | Alteplase alone (n = 396) | Argatroban plus alteplase (n = 402) | Alteplase alone (n = 415) | |
| Age, median (IQR), y | 66 (58-72) | 64 (56-71) | 66 (58-72) | 64 (56-71) |
| Sex | ||||
| Men | 249 (68.4) | 289 (73.0) | 271/397 (68.3) | 299/411 (72.7) |
| Women | 115 (31.6) | 107 (27.0) | 126/397 (31.7) | 112/411 (27.3) |
| Currently smokes tobacco | 131 (36.0) | 141 (35.6) | 141/396 (35.6) | 143/411 (34.8) |
| Currently drinks alcohola | 69/354 (19.5) | 69/389 (17.7) | 73/386 (18.9) | 69/404 (17.1) |
| Comorbiditiesb | ||||
| Hypertension | 203 (55.8) | 223 (56.3) | 216/397 (54.4) | 232/411 (56.4) |
| Diabetes | 91 (25.0) | 81 (20.5) | 100/397 (25.2) | 87/410 (21.2) |
| Prior ischemic or hemorrhagic strokec | 74 (20.3) | 68 (17.2) | 82/397 (20.7) | 74/411 (18.0) |
| Atrial fibrillation | 18/346 (5.2) | 21/378 (5.6) | 19/365 (5.2) | 22/388 (5.7) |
| Hyperlipidemia | 3 (0.8) | 3 (0.8) | 3/397 (0.8) | 4/411 (1.0) |
| Prior transient ischemic attack | 3 (0.8) | 4 (1.0) | 3/397 (0.8) | 5/411 (1.2) |
| Body mass index, median (IQR) | 22.9 (21.0-24.0) | 23.7 (21.0-24.0) | 22.7 (20.1-24.0) | 23.5 (21.0-24.0) |
| Blood pressure at randomization | ||||
| Systolic | ||||
| Median (IQR), mm Hg | 154 (139-170) | 150 (136-166) | 152 (138-170) | 150 (136-165) |
| >140 mm Hg | 242 (66.5) | 250 (63.1) | 257/397 (64.7) | 250/411 (60.8) |
| Diastolic | ||||
| Median (IQR), mm Hg | 90 (80-98) | 88 (80-97) | 90 (80-98) | 88 (80-97) |
| >90 mm Hg | 142 (39.0) | 142 (35.9) | 151/397 (38.0) | 145/411 (35.3) |
| Blood glucose | ||||
| Median (IQR), mg/dL | 118.8 (102.8-164.0) | 121.0 (102.6-160.7) | 120.8 (102.6-162.2) | 120.6 (102.6-163.8) |
| >126 mg/dL | 128/293 (43.7) | 143/324 (44.1) | 144/321 (44.9) | 150/335 (44.8) |
| NIHSS score at randomization, median (IQR)d | 9 (7-12) | 8 (6-12) | 9 (7-12) | 9 (6-12) |
| GRASPS score at randomization, median (IQR)e | 75 (71-79) | 74 (70-78) | 75 (71-79) | 74 (70-78) |
| ASPECTS score at randomization, median (IQR)f | 9 (8-10) | 9 (8-10) | 9 (8-10) | 9 (8-10) |
| Estimated premorbid function (mRS score)g | ||||
| No symptoms (score of 0) | 295 (81.0) | 314 (79.3) | 318/397 (80.1) | 326/411 (79.3) |
| Symptoms without any disability (score of 1) | 65 (17.9) | 76 (19.2) | 75/397 (18.9) | 79/411 (19.2) |
| Mild disability (score of 2) | 4 (1.1) | 6 (1.5) | 4/397 (1.0) | 6/411 (1.5) |
| Presumed stroke causeh | ||||
| Undetermined | 233/356 (65.4) | 270/389 (69.4) | 242/370 (65.4) | 276/401 (68.8) |
| Large artery atherosclerosis | 67/356 (18.8) | 74/389 (19.0) | 71/370 (19.2) | 76/401 (19.0) |
| Small artery occlusion | 33/356 (9.3) | 29/389 (7.5) | 34/370 (9.2) | 33/401 (8.2) |
| Cardioembolic | 20/356 (5.6) | 15/389 (3.9) | 20/370 (5.4) | 15/401 (3.7) |
| Other | 3/356 (0.8) | 1/389 (0.3) | 3/370 (0.8) | 1/401 (0.2) |
| Location of responsible vesseli | ||||
| Anterior stroke | 157/195 (80.5) | 153/200 (76.5) | 167/205 (81.5) | 162/209 (77.5) |
| Posterior stroke | 33/195 (16.9) | 43/200 (21.5) | 33/205 (16.1) | 43/209 (20.6) |
| Anterior and posterior stroke | 5/195 (2.6) | 4/200 (2.0) | 5/205 (2.4) | 4/209 (1.9) |
| Location of responsible artery (≥50% stenosis)i | ||||
| Internal carotid | 18/75 (24.0) | 16/85 (18.8) | 20/82 (24.4) | 16/88 (18.2) |
| Middle cerebral | 44/75 (58.7) | 49/85 (57.6) | 47/82 (57.3) | 52/88 (59.1) |
| Anterior cerebral | 2/75 (2.7) | 5/85 (5.9) | 2/82 (2.4) | 5/88 (5.7) |
| Posterior cerebral | 4/75 (5.3) | 5/85 (5.9) | 4/82 (4.9) | 5/88 (5.7) |
| Basilar | 5/75 (6.7) | 6/85 (7.1) | 5/82 (6.1) | 6/88 (6.8) |
| Vertebral | 4/75 (5.3) | 4/85 (4.7) | 4/82 (4.9) | 4/88 (4.5) |
| Time from symptom onset to alteplase, median (IQR), min | 160 (120-208) | 155 (114-201) | 160 (120-208) | 156 (115-201) |
| Time from symptom onset to discharge, median (IQR), d | 10 (7-13) | 9 (7-13) | 10 (7-12) | 10 (6-13) |
| Endovascular treatment | 10 (2.7) | 13 (3.3) | 15/397 (3.7) | 17/411 (4.1) |
Defined as consuming alcohol at least once a week within 1 year prior to the onset of the disease.
Comorbidities based on family or patient report.
Prior ischemic stroke referred only to the patients with premorbid modified Rankin Scale (mRS) scores ≤1.
Scores on National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe neurologic deficit; a mean NIHSS score of 8 to 9 indicates moderate neurologic deficit.
The GRASPS score uses 6 clinical variables to estimate risk of symptomatic intracranial hemorrhage after intravenous alteplase and ranges from 0 to 101, with higher scores indicating greater risk.
The Alberta Stroke Program Early CT Score (ASPECTS) determines the extent of ischemic tissue based on computed tomography imaging. Scores range from 0 to 10, with higher scores indicating less infarct volume.
Scores on the mRS of functional disability range from 0 (no symptoms) to 6 (death).
The presumed stroke cause was classified according to the Trial of ORG 10172 in Acute Stroke Treatment (TOAST) using clinical findings, brain imaging, and laboratory test results. Other causes included nonatherosclerotic vasculopathies, hypercoagulable states, and hematologic disorder.
Definite conclusions based on vessel examination. The diagnosis was based on the clinician’s interpretation of the clinical features and examination results at the time of hospital discharge.