| Variable | Darexaban, 5 mg b.i.d. | Darexaban, 10 mg o.d. | Darexaban, 15 mg b.i.d. | Darexaban, 30 mg o.d. | Darexaban, 30 mg b.i.d. | Darexaban, 60 mg o.d. | Placebo |
|---|---|---|---|---|---|---|---|
| n | 159 | 159 | 159 | 156 | 153 | 153 | 319 |
| Age, mean (SD) | 57.4 (10.43) | 57.1 (10.35) | 56.3 (9.58) | 56.1 (10.05) | 57.2 (11.53) | 55.7 (10.39) | 57.5 (10.44) |
| Female, % | 20.8 | 21.4 | 18.2 | 16.0 | 21.6 | 17.0 | 24.1 |
| Ethnicity, n (%) | |||||||
| Caucasian | 124 (78.0) | 123 (77.4) | 124 (78.0) | 126 (80.8) | 117 (76.5) | 120 (78.4) | 257 (80.6) |
| Black/African American | 2 (1.3) | 4 (2.5) | 1 (0.6) | 0 (0.0) | 1 (0.7) | 0 (0.0) | 0 (0.0) |
| Asian | 27 (17.0) | 28 (17.6) | 30 (18.9) | 26 (16.7) | 28 (18.3) | 27 (17.6) | 54 (16.9) |
| Other | 6 (3.8) | 4 (2.5) | 4 (2.5) | 4 (2.6) | 7 (4.6) | 6 (3.9) | 8 (2.5) |
| Enrolment region, n (%) | |||||||
| Europe | 108 (67.9) | 108 (67.9) | 108 (67.9) | 108 (69.2) | 104 (68.0) | 105 (68.6) | 219 (68.7) |
| North America | 9 (5.7) | 7 (4.4) | 7 (4.4) | 8 (5.1) | 7 (4.6) | 7 (4.6) | 15 (4.7) |
| Central/South America | 11 (6.9) | 13 (8.2) | 11 (6.9) | 10 (6.4) | 12 (7.8) | 11 (7.2) | 24 (7.5) |
| Asia/Pacific/South Africa | 31 (19.5) | 31 (19.5) | 33 (20.8) | 30 (19.2) | 30 (19.6) | 30 (19.6) | 61 (19.1) |
| Smoker, n (%) | |||||||
| Former | 42 (26.4) | 34 (21.4) | 31 (19.5) | 33 (21.2) | 33 (21.6) | 41 (26.8) | 83 (26.0) |
| Current | 69 (43.4) | 65 (40.9) | 68 (42.8) | 63 (40.4) | 62 (40.5) | 64 (41.8) | 140 (43.9) |
| Never | 48 (30.2) | 60 (37.7) | 60 (37.7) | 60 (38.5) | 58 (37.9) | 48 (31.4) | 96 (30.1) |
| Hypertension, n (%) | 90 (56.6) | 99 (62.3) | 95 (59.7) | 91 (58.3) | 95 (62.1) | 96 (62.7) | 194 (60.8) |
| Dyslipidaemia, n (%) | 77 (48.4) | 74 (46.5) | 77 (48.4) | 89 (57.1) | 76 (49.7) | 81 (52.9) | 153 (48.0) |
| Diabetes mellitus Type 2, n (%) | 39 (24.5) | 37 (23.3) | 37 (23.3) | 43 (27.6) | 34 (22.2) | 27 (17.6) | 60 (18.8) |
| Primary diagnosis for index event, n (%) | |||||||
| STEMI | 111 (69.8) | 121 (76.1) | 119 (74.8) | 106 (67.9) | 108 (70.6) | 109 (71.2) | 220 (69.0) |
| NSTEMI | 48 (30.2) | 38 (23.9) | 40 (25.2) | 50 (32.1) | 45 (29.4) | 44 (28.8) | 99 (31.0) |
| Use of PCI for index event | 122 (76.7) | 116 (73.0) | 119 (74.8) | 115 (73.7) | 118 (77.1) | 113 (73.9) | 235 (73.7) |
| Standard antiplatelet therapy, n (%) | |||||||
| With clopidogrel | 154 (96.9) | 152 (95.6) | 152 (95.6) | 152 (97.4) | 148 (96.7) | 148 (96.7) | 309 (96.9) |
| Without clopidogrel | 5 (3.1) | 7 (4.4) | 7 (4.4) | 4 (2.6) | 5 (3.3) | 5 (3.3) | 10 (3.1) |
| Time from index event to first dose (mean days) | 4.1 | 4.0 | 4.3 | 3.8 | 4.1 | 4.2 | 4 |
| GRACE risk score at presentation (evaluated population) | 132.6 (n = 158) | 134.7 (n = 156) | 135.1 (n = 156) | 130.6 (n = 154) | 132.3 (n = 152) | 131.2 (n = 153) | 132.8 (n = 314) |
| Hx of prior CHF, n (%) | 4 (2.5) | 3 (1.9) | 6 (3.8) | 2 (1.3) | 3 (2.0) | 4 (2.6) | 8 (2.5) |
| Hx of stroke/TIA, n (%) | 3 (1.9) | 4 (2.5) | 4 (2.5) | 8 (5.1) | 6 (3.9) | 6 (3.9) | 6 (1.9) |
| Hx of prior MI, n (%) | 19 (11.9) | 9 (5.7) | 17 (10.7) | 24 (15.4) | 18 (11.8) | 18 (11.8) | 45 (14.1) |
| Hx of CABG, n (%) | 8 (5.0) | 3 (1.9) | 1 (0.6) | 5 (3.2) | 3 (2.0) | 5 (3.3) | 6 (1.9) |
| Hx of PCI, n (%) | 10 (6.3) | 8 (5.0) | 13 (8.2) | 13 (8.3) | 22 (14.4) | 20 (13.1) | 25 (7.8) |
| Peripheral arterial disease, n (%) | 9 (5.7) | 4 (2.5) | 6 (3.8) | 5 (3.2) | 4 (2.6) | 4 (2.6) | 13 (4.0) |
| Premature permanent study drug discontinuation, n (%) | 30 (18.9) | 31 (19.5) | 32 (20.1) | 44 (28.2) | 50 (32.7) | 36 (23.5) | 68 (21.3) |
| Duration of drug exposure, median weeks (Q1, Q3) | 26.0 (23.9, 26.1) | 26.0 (24.3, 26.1) | 26.0 (19.6, 26.1) | 26.0 (20.6, 26.1) | 25.7 (11.6, 26.1) | 26.0 (17.7, 26.1) | 26.0 (25.0, 26.1) |
| Concomitant medications, n (%) | |||||||
| Beta-blockers | 146 (91.8) | 147 (92.4) | 149 (93.7) | 145 (92.9) | 139 (90.8) | 133 (86.9) | 293 (91.8) |
| ACE-inhibitors | 128 (80.5) | 126 (79.2) | 121 (76.1) | 117 (75.0) | 123 (80.4) | 116 (75.8) | 248 (77.7) |
| Angiotensin receptor blockers | 17 (11.0) | 23 (14.5) | 25 (15.7) | 17 (10.9) | 19 (12.4) | 23 (15.0) | 43 (13.5) |
| Statins | 150 (94.3) | 154 (96.9) | 156 (98.1) | 146 (93.6) | 146 (95.4) | 145 (94.8) | 304 (95.3) |
| Fibrates | 4 (2.5) | 6 (3.8) | 3 (1.9) | 5 (3.2) | 2 (1.3) | 5 (3.3) | 10 (3.1) |
| PPIs | 50 (31.4) | 49 (30.8) | 47 (29.6) | 67 (42.9) | 63 (41.2) | 60 (39.2) | 99 (31.0) |
| Variable | Darexaban, b.i.d. | Darexaban, o.d. | Darexaban, 10 mg doses | Darexaban, 30 mg doses | Darexaban, 60 mg doses | Darexaban, total | Grand total |
| n | 471 | 468 | 318 | 315 | 306 | 939 | 1258 |
| Age, mean (SD) | 57.0 (10.52) | 56.3 (10.26) | 57.2 (10.37) | 56.2 (9.80) | 56.5 (10.98) | 56.6 (10.39) | 56.9 (10.4) |
| Female, % | 20.2 | 18.2 | 21.1 | 17.1 | 19.3 | 19.2 | 20.4 |
| Ethnicity, n (%) | |||||||
| Caucasian | 365 (77.5) | 369 (78.8) | 247 (77.7) | 250 (79.4) | 237 (77.5) | 734 (78.2) | 991 (78.8) |
| Black/African American | 4 (0.8) | 4 (0.9) | 6 (1.9) | 1 (0.3) | 1 (0.3) | 8 (0.9) | 8 (0.6) |
| Asian | 85 (18.0) | 81 (17.3) | 55 (17.3) | 56 (17.8) | 55 (18.0) | 166 (17.7) | 220 (17.5) |
| Other | 17 (3.6) | 14 (3.0) | 10 (3.1) | 8 (2.5) | 13 (4.2) | 31 (3.3) | 39 (3.1) |
| Enrolment region, n (%) | |||||||
| Europe | 320 (67.9) | 321 (68.6) | 216 (67.9) | 216 (68.6) | 209 (68.3) | 641 (68.3) | 860 (68.4) |
| North America | 23 (4.9) | 22 (4.7) | 16 (5.0) | 15 (4.8) | 14 (4.6) | 45 (4.8) | 60 (4.8) |
| Central/South America | 34 (7.2) | 34 (7.3) | 24 (7.5) | 21 (6.7) | 23 (7.5) | 68 (7.2) | 92 (7.3) |
| Asia/Pacific/South Africa | 94 (20.0) | 91 (19.4) | 62 (19.5) | 63 (20.0) | 60 (19.6) | 185 (19.7) | 246 (19.6) |
| Smoker, n (%) | |||||||
| Former | 106 (22.5) | 108 (23.1) | 76 (23.9) | 64 (20.3) | 74 (24.2) | 214 (22.8) | 297 (23.6) |
| Current | 199 (42.3) | 192 (41.0) | 134 (42.1) | 131 (41.6) | 126 (41.2) | 391 (41.6) | 531 (42.2) |
| Never | 166 (35.2) | 168 (35.9) | 108 (34.0) | 120 (38.1) | 106 (34.6) | 334 (35.6) | 430 (34.2) |
| Hypertension, n (%) | 280 (59.4) | 286 (61.1) | 189 (59.4) | 186 (59.0) | 191 (62.4) | 566 (60.3) | 760 (60.4) |
| Dyslipidaemia, n (%) | 230 (48.8) | 244 (52.1) | 151 (47.5) | 166 (52.7) | 157 (51.3) | 474 (50.5) | 627 (49.8) |
| Diabetes mellitus Type 2, n (%) | 110 (23.4) | 107 (22.9) | 76 (23.9) | 80 (25.4) | 61 (19.9) | 217 (23.1) | 277 (22.0) |
| Primary diagnosis for index event, n (%) | |||||||
| STEMI | 338 (71.8) | 336 (71.8) | 232 (73.0) | 225 (71.4) | 217 (70.9) | 674 (71.8) | 894 (71.1) |
| NSTEMI | 133 (28.2) | 132 (28.2) | 86 (27.0) | 90 (28.6) | 89 (29.1) | 265 (28.2) | 364 (28.9) |
| Use of PCI for index event, n (%) | 359 (76.2) | 344 (73.5) | 238 (74.8) | 234 (74.3) | 231 (75.5) | 703 (74.9) | 938 (74.6) |
| Standard antiplatelet therapy, n (%) | |||||||
| With clopidogrel | 454 (96.4) | 452 (96.6) | 306 (96.2) | 304 (96.5) | 296 (96.7) | 906 (96.5) | 1215 (96.6) |
| Without clopidogrel | 17 (3.6) | 16 (3.4) | 12 (3.8) | 11 (3.5) | 10 (3.3) | 33 (3.5) | 43 (3.4) |
| Time from index event to first dose (mean days) | 4.2 | 4.0 | 4.1 | 4.1 | 4.1 | 4.1 | 4.1 |
| GRACE risk score at presentation (evaluated population) | 133.3 (n = 466) | 132.2 (n = 463) | 133.6 (n = 314) | 132.9 (n = 310) | 131.8 (n = 305) | 132.8 (n = 929) | 132.8 (n = 1243) |
| Hx of prior CHF, n (%) | 13 (2.8) | 9 (1.9) | 7 (2.2) | 8 (2.5) | 7 (2.3) | 22 (2.3) | 30 (2.4) |
| Hx of stroke/TIA, n (%) | 13 (2.8) | 18 (3.8) | 7 (2.2) | 12 (3.8) | 12 (3.9) | 31 (3.3) | 37 (2.9) |
| Hx of prior MI, n (%) | 54 (11.5) | 51 (10.9) | 28 (8.8) | 41 (13.0) | 36 (11.8) | 105 (11.2) | 150 (11.9) |
| Hx of CABG, n (%) | 12 (2.5) | 13 (2.8) | 11 (3.5) | 6 (1.9) | 8 (2.6) | 25 (2.7) | 31 (2.5) |
| Hx of PCI, n (%) | 45 (9.6) | 41 (8.8) | 18 (5.7) | 26 (8.3) | 42 (13.7) | 86 (9.2) | 111 (8.8) |
| Peripheral arterial disease, n (%) | 19 (4.0) | 13 (2.8) | 13 (4.1) | 11 (3.5) | 8 (2.6) | 32 (3.4) | 45 (3.6) |
| Premature permanent study drug discontinuation, n (%) | 112 (23.8) | 111 (23.7) | 61 (19.2) | 76 (24.1) | 86 (28.1) | 223 (23.7) | 291 (23.1) |
| Duration of drug exposure, median weeks (Q1,Q3) | 26.0 (19.1, 26.1) | 26.0 (21.9, 26.1) | 26.0 (24.1, 26.1) | 26.0 (19.6, 26.1) | 26.0 (13.1, 26.1) | 26.0 (20.0, 26.1) | 26.0 (22.0, 26.1) |
| Concomitant medications, n (%) | |||||||
| Beta-blockers | 434 (92.1) | 425 (90.8) | 293 (92.1) | 294 (93.3) | 272 (88.9) | 859 (91.5) | 1152 (91.6) |
| ACE-inhibitors | 372 (79.0) | 359 (76.7) | 254 (79.9) | 238 (75.6) | 239 (78.1) | 731 (77.8) | 979 (77.8) |
| Angiotensin receptor blockers | 61 (13.0) | 63 (13.5) | 40 (12.6) | 42 (13.3) | 42 (13.7) | 124 (13.2) | 167 (13.3) |
| Statins | 452 (96.0) | 445 (95.1) | 304 (95.6) | 302 (95.9) | 291 (95.1) | 897 (95.5) | 1201 (95.5) |
| Fibrates | 9 (1.9) | 16 (3.4) | 10 (3.1) | 8 (2.5) | 7 (2.3) | 25 (2.7) | 35 (2.8) |
| PPIs | 160 (34.0) | 176 (37.6) | 99 (31.1) | 114 (36.2) | 123 (40.2) | 336 (35.8) | 435 (34.6) |
SD, standard deviation; STEMI, ST-segment elevation; NSTEMI, non-ST-segment; PCI, percutaneous coronary intervention; GRACE, Global Registry of Acute Coronary Events; Hx, history; CHF, chronic heart failure; TIA, transient ischaemic attack; MI, myocardial infarction; CABG, coronary artery bypass graft; PPI, proton pump inhibitor; Q, quartile; ACE, angiotensin-converting enzyme.