Table 1.
Baseline characteristics of ASPIRED trial participants (N=180)
| Placebo (n=60) | Aspirin, 81 mg (n=60) | Aspirin, 325 mg (n=60) | |
|---|---|---|---|
| Age, yr, mean (SD) | 57.1 (9.2) | 56.1 (8.7) | 57.5 (8.3) |
| Sex, n (%)a | |||
| Female | 28 (46.7) | 29 (48.3) | 28 (46.7) |
| Race, n (%) | |||
| White | 55 (91.7) | 52 (86.7) | 53 (88.3) |
| Black/African American | 3 (5.0) | 4 (6.7) | 3 (5.0) |
| Asian | 1 (1.7) | 0 (0) | 2 (3.3) |
| More than one race | 0 (0) | 4 (6.7) | 2 (3.3) |
| Did not report | 1 (1.7) | 0 (0) | 0 (0) |
| Ethnicity, n (%) | |||
| Hispanic | 2 (3.3) | 2 (3.3) | 1 (1.7) |
| Marital Status, n (%) | |||
| Married | 40 (66.7) | 39 (65.0) | 37 (61.7) |
| Never married | 6 (10.0) | 12 (20.0) | 11 (18.3) |
| Separated | 2 (3.3) | 0 (0.0) | 1 (1.7) |
| Divorced | 8 (13.3) | 7 (11.7) | 7 (11.7) |
| Widowed | 4 (6.7) | 2 (3.3) | 4 (6.7) |
| Body Mass Index, kg/m2, mean (SD) | 26.8 (5.0) | 28.4 (4.9) | 27.5 (5.7) |
| Normal, <18.5–24.9 | 21 (35.0) | 16 (26.7) | 21 (35.0) |
| Overweight, 25.0–29.9 | 26 (43.3) | 26 (43.3) | 23 (38.3) |
| Obese, ≥30.0 | 13 (21.7) | 18 (30.0) | 16 (26.7) |
| Smoking Status, n (%) | |||
| Never | 38 (63.3) | 36 (60.0) | 32 (53.3) |
| Former | 18 (30.0) | 20 (33.3) | 19 (31.7) |
| Current | 4 (6.7) | 3 (5.0) | 8 (13.3) |
| Missing | 0 (0.0) | 1 (1.7) | 1 (1.7) |
| Alcohol Consumption, n (%) | |||
| Never | 7 (11.7) | 11 (18.3) | 11 (18.3) |
| Rarely | 14 (23.3) | 16 (26.7) | 18 (30.0) |
| 1–5 times/week | 29 (48.3) | 24 (40.0) | 23 (38.3) |
| Daily | 10 (16.7) | 8 (13.3) | 6 (10.0) |
| More than daily | 0 (0.0) | 1 (1.7) | 2 (3.3) |
| Personal Cancer History, yes, n (%) | 10 (17.0) | 6 (10.0) | 4 (6.8) |
| Family History of CRC, yes, n (%) | 13 (21.7) | 10 (16.7) | 12 (20.0) |
| Type II Diabetes, yes, n (%) | 2 (3.4) | 3 (5.0) | 2 (3.3) |
| Menopause Status (n=85)b | |||
| Pre-menopausal | 3 (10.7) | 9 (31.0) | 5 (17.9) |
| Peri-menopausal | 4 (14.3) | 1 (3.4) | 2 (7.1) |
| Post-menopausal | 20 (71.4) | 17 (58.6) | 18 (64.3) |
| Missing | 1 (3.6) | 2 (6.9) | 3 (10.7) |
| History of 81 mg aspirin use, n (%) | |||
| Never | 55 (91.7) | 50 (83.3) | 53 (88.3) |
| Intermittently (<2x/wk) | 2 (3.3) | 5 (8.3) | 5 (8.3) |
| Regularly (>2x/week) | 2 (3.3) | 2 (3.3) | 2 (3.3) |
| Missing | 1 (1.7) | 3 (5.0) | 0 (0.0) |
| History of 325 mg aspirin use, n (%) | |||
| Never | 40 (66.7) | 42 (70.0) | 42 (70.0) |
| Intermittently (<2x/wk) | 17 (28.3) | 15 (25.0) | 17 (28.3) |
| Regularly (>2x/week) | 1 (1.7) | 1 (1.7) | 1 (1.7) |
| Missing | 2 (3.3) | 2 (3.3) | 0 (0.0) |
| History of NSAID use, n (%) | |||
| Never | 18 (30.0) | 13 (21.7) | 19 (31.7) |
| Intermittently (<2x/wk) | 31 (51.7) | 36 (60.0) | 32 (53.3) |
| Regularly (>2x/week) | 10 (16.7) | 9 (15.0) | 8 (13.3) |
| Missing | 1 (1.7) | 2 (3.3) | 1 (1.7) |
| PPI Use, n (%) | |||
| Current and regular | 5 (8.3) | 6 (10.0) | 8 (13.3) |
| Missing | 7 (11.7) | 5 (8.3) | 4 (6.7) |
| H2-Blocker Use, n (%) | |||
| Current and regular | 2 (3.3) | 5 (8.3) | 2 (3.3) |
| Missing | 2 (3.3) | 1 (1.7) | 1 (1.7) |
| Antacid Use, n (%) | |||
| Current and regular | 5 (8.3) | 3 (5.0) | 3 (5.0) |
| Missing | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Statin Use, n (%) | |||
| Current and regular | 14 (23.3) | 11 (18.3) | 16 (26.7) |
| Missing | 2 (3.3) | 1 (1.7) | 1 (1.7) |
| Indication for Previous Endoscopy, n (%) | |||
| Screening | 35 (58.3) | 33 (55.0) | 30 (50.0) |
| Surveillance | 15 (25.0) | 13 (21.7) | 16 (26.7) |
| Diagnostic | 3 (5.0) | 5 (8.3) | 3 (5.0) |
| Other/Unknown | 7 (11.7) | 9 (15.0) | 11 (18.3) |
| Polyp History by location, n (%) | |||
| Right | 23 (38.3) | 25 (41.7) | 26 (43.3) |
| Left | 24 (40.0) | 14 (23.3) | 17 (28.3) |
| Both | 13 (21.7) | 21 (35.0) | 16 (26.7) |
| Unknown | 0 (0.0) | 0 (0.0) | 1 (1.7) |
| Days on treatment, mean (SD)c | 68.6 (6.5) | 68.5 (7.5) | 69.6 (6.9) |
| Pill Count Adherence, n (%)c | |||
| 95.0–100% | 52 (89.7) | 45 (79.3) | 49 (90.7) |
| 90.0–94.9% | 3 (5.2) | 9 (15.5) | 3 (5.6) |
| 80.0–89.9% | 1 (1.7) | 3 (5.2) | 2 (3.7) |
| <80.0% | 1 (1.7) | 0 (0.0) | 0 (0.0) |
| Missing | 1 (1.7) | 0 (0.0) | (0.0) |
Baseline characteristics of subjects were compared between treatment arms by using Fisher’s exact test for categorical variables and one-way ANOVA and unpaired two sample t-tests for continuous variables.
a
Biological sex at birth.
b
Question posed only to women.
c
Only available for individuals who completed the study and provided a pre- and post-treatment sample (n=169). Missing represents one individual who completed the study, but did not return their pill bottle to the study staff.