TABLE 1.
Participant demographics for the study cohort
| Participants who consented and were randomized (N = 65) | Participants who completed the protocol (N = 55) | |||||
|---|---|---|---|---|---|---|
| Variable | All | Placebo followed by tadalafil | Tadalafil followed by placebo | All | Placebo followed by tadalafil | Tadalafil followed by placebo |
| N | 65 | 32 | 33 | 55 | 25 | 30 |
| Age (y) | 66.7 | 68.0 | 65.5 | 66.8 | 67.9 | 65.9 |
| (8.7) | (8.4) | (9.0) | (8.6) | (8.4) | (8.9) | |
| Age range (y) | 52, 87 | 53, 87 | 52, 83 | 52, 87 | 53, 87 | 52, 83 |
| Female/male | 19/46 | 14/18 | 5/28 | 15/40 | 10/15 | 5/25 |
| MoCA score | 25.4 | 25.4 | 25.4 | 25.1 | 25.0 | 25.2 |
| (3.4) | (3.3) | (3.6) | (3.5) | (3.4) | (3.7) | |
| Education (y) | 12.8 (3.1) | 12.7 (2.9) | 12.8 (3.3) | 12.7 (3.2) | 12.7 (3.0) | 12.7 (3.4) |
| Time from stroke to consent (months) | 16.0 | 15.3 | 16.8 | 14.6 | 14.9 | 14.3 |
| (17.6) | (12.0) | (22.6) | (12.1) | (11.8) | (12.8) | |
| Modified Rankin score (0/1/2/3/4/5–6) | 18/26/16/3/2/0 | 7/13/10/2/0/0 | 11/13/6/1/2/0 | 16/20/14/3/2/0 | 5/10/8/2/ | 11/10/6/1/ |
| 2/0 | 0/0 | 2/0 | 2/0 | 0/0 | 2/0 | |
| NIHSS (range 0–42) | 1.0 | 1.0 | 1.0 | 1.0 | 1.0 | 0.5 |
| [0.0, 2.0] | [0.0, 2.0] | [0.0, 2.0] | [0.0, 2.0] | [0.0, 3.0] | [0.0, 2.0] | |
| WMH volume (mm3) | NA | NA | NA | 14,600 | 15,700 | 11,800 |
| [7,200, 31,700] | [9,200, 34,500] | [6,800, 27,600] | ||||
| Cerebral microbleeds, total count | 1 [0, 4] | 1 [0, 4] | 1 [0, 4] | 1 [0, 4] | 1.5 [0, 4] | 1 [0, 4.5] |
| SBP (mm Hg) | 145 | 147 | 144 | 145 | 147 | 144 |
| (16.6) | (17.1) | (16.4) | (16.6) | (18.7) | (14.8) | |
| DBP (mm Hg) | 81.0 | 81.0 | 81.0 | 79.9 | 79.2 | 80.5 |
| (10.7) | (9.6) | (11.9) | (10.7) | (9.7) | (11.6) | |
Notes: Data are reported as mean (SD), except for modified Rankin score (actual scores listed), NIHSS score, WMH volume, and cerebral microbleed counts, which are reported as median [interquartile range]. Scoring in MoCA ranges from 0 to 30, with a score of 26 or higher indicating normal cognitive ability. These scores have been adjusted for educational level (+1 if the participant had 12 or more years of education). SBP, DBP are the average over Visit#1 and Visit#2.
Abbreviations: DBP, diastolic blood pressure; MoCA, Montreal Cognitive Assessment; NIHSS, National Institutes of Health Stroke Scale; SBP, systolic blood pressure; SD, standard deviation; WMH, white matter hyperintensities.