Table 2.
Baseline Clinical Measures and Demographics
| Placebo (N=68) | GSK249320 (N=65) | |
|---|---|---|
|
| ||
| Age (years)* | 67.1±11.2 | 68.2±11.9 |
|
| ||
| Sex (F/M) | 29/39 | 31/34 |
|
| ||
| Hypertension | 51 | 47 |
|
| ||
| Diabetes Mellitus | 22 | 18 |
|
| ||
| Hyperlipidemia | 36 | 28 |
|
| ||
| Atrial fibrillation | 18 | 17 |
|
| ||
| History of Angina Pectoris/MI | 1 | 1 |
|
| ||
| History of Stroke | 0 | 0 |
|
| ||
| Ethnicity | ||
| Hispanic/Latino | 0 | 1 |
| Not Hispanic/Latino | 68 | 64 |
|
| ||
| Race | ||
| White | 62 | 62 |
| African-American/African Heritage | 4 | 2 |
| American Indian/Alaskan Native | 1 | 0 |
| Asian | 1 | 1 |
|
| ||
| Received IV tPA | 29 | 25 |
|
| ||
| Received IA Reperfusion Therapy | 3 | 9 |
|
| ||
| Stroke Subtype | ||
| Large-artery atherosclerosis | 24 | 20 |
| Cardioembolism | 19 | 25 |
| Small-vessel occlusion | 10 | 9 |
| Ischemic stroke other determined etiology | 2 | 2 |
| Ischemic stroke undetermined etiology | 13 | 9 |
|
| ||
| Gait Impairment Stratification | ||
| 0 | 55 | 53 |
| >0–<0.4 | 5 | 5 |
| 0.4–0.8 | 8 | 6 |
| >0.8 | 0 | 1 |
|
| ||
| NIHSS Total Score at Day 1, median (range) | 9.5 (3–20) | 10.0 (3–19) |
|
| ||
| NIHSS Q6 Leg Deficit, Day 1* | 2.4±1.20 | 2.1±1.09 |
|
| ||
| NIHSS Q5 Arm Deficit, Day 1* | 2.7±1.29 | 2.4±1.34 |
|
| ||
| Box & Blocks Score, Day 1* | ||
| Stroke-affected arm | 3.2±7.7 | 4.2±8.4 |
| Non-stroke arm | 25.1±13.3 | 23.3±12.4 |
|
| ||
| Hours, Stroke Onset-First IP Infusion* | 52.7±14.4 | 52.4±13.3 |
Values are for Safety population, except Box & Blocks Score Day 1=Per Protocol population.
*
mean±SD