Table 1.
Patient demography including risk factors for stroke and concomitant conditions at randomization
| AZD0837 150 mg od (n = 164) | AZD0837 300 mg od (n = 151) | AZD0837 450 mg od (n = 156) | AZD0837 200 mg bid (n = 160) | Total AZD0837 (n = 631) | VKA INR 2–3 (n = 318) | |
|---|---|---|---|---|---|---|
| VKA naïve, % | 28.0 | 27.2 | 26.9 | 30.6 | 28.2 | 30.2 |
| Age in years, mean (range) | 69.9 (43–93) | 69.8 (45–92) | 69.3 (45–88) | 67.8 (34–88) | 69.2 (34–93) | 68.3 (33–87) |
| Gender, male, % | 71.3 | 68.9 | 68.6 | 66.9 | 68.9 | 67.6 |
| Weight in kg, mean (range) | 86.4 (47.0–130.0) | 86.6 (51.0–143.0) | 86.2 (49.0–134.0) | 87.2 (53.0–167.0) | 86.6 (47.0–167.0) | 86.9 (48.0–150.0) |
| BMI in kg/m2, mean (range) | 29.1 (18.8–44.5) | 29.3 (19.0–50.0) | 29.0 (18.9–43.4) | 29.5 (19.6–47.8) | 29.2 (18.8–50.0) | 29.3 (17.8–48.1) |
| Risk factors for stroke in addition to AF, number (%) | ||||||
| At least one risk factor for stroke in addition to AF | 164 (100) | 151 (100) | 156 (100) | 160 (100) | 631 (100) | 318 (100) |
| Previous cerebral ischaemic attack (stroke or TIA) | 19 (11.6) | 21 (13.9) | 24 (15.4) | 28 (17.5) | 92 (14.6) | 47 (14.8) |
| Previous systemic embolism | 2 (1.2) | 4 (2.6) | 3 (1.9) | 4 (2.5) | 13 (2.1) | 3 (0.9) |
| Age ≥75 years | 58 (35.4) | 53 (35.1) | 51 (32.7) | 35 (21.9) | 197 (31.2) | 87 (27.4) |
| Symptomatic CHF | 62 (37.8) | 50 (33.1) | 58 (37.2) | 52 (32.5) | 222 (35.2) | 130 (40.9) |
| Impaired left ventricular systolic function | 41 (25.0) | 31 (20.5) | 38 (24.4) | 40 (25.0) | 150 (23.8) | 79 (24.8) |
| Diabetes mellitus | 32 (19.5) | 26 (17.2) | 42 (26.9) | 42 (26.3) | 142 (22.5) | 96 (30.2) |
| Hypertension requiring antihypertensive treatment | 142 (86.6) | 123 (81.5) | 124 (79.5) | 137 (85.6) | 526 (83.4) | 253 (79.6) |
| Other concomitant cardiovascular condition, number (%) | ||||||
| Coronary artery diseasea | 56 (34.1) | 70 (46.4) | 61 (39.1) | 57 (35.6) | 244 (38.7) | 132 (41.5) |
| Dyslipidaemia | 73 (44.5) | 74 (49.0) | 80 (51.3) | 82 (51.3) | 309 (49.0) | 161 (50.6) |
| Cardiac failure | 68 (41.5) | 56 (37.1) | 60 (38.5) | 56 (35.0) | 240 (38.0) | 139 (43.7) |
| Peripheral arterial disease | 8 (4.9) | 6 (4.0) | 9 (5.8) | 7 (4.4) | 30 (4.8) | 17 (5.3) |
AF, atrial fibrillation; BMI, body mass index; CHF, congestive heart failure; INR, international normalized ratio; VKA, vitamin K antagonist; TIA, transient ischaemic attack.
aCoronary artery disease: angina pectoris, coronary artery bypass surgery, myocardial infarction, or percutaneous coronary intervention including percutaneous transluminal coronary angioplasty with or without stent.