Baseline patient characteristics in the analysis
| SBP<140 mm Hg | SBP≥140 mm Hg | P value§§ | |||||||
| Total patients (N=950) | Clopidogrel plus aspirin (N=496) | Aspirin alone (N=454) | P value | Total patients (N=1965) | Clopidogrel plus aspirin (N=1006) | Aspirin alone (N=959) | P value | ||
| Age, years | 65 (58–73) | 66 (58–73) | 65 (59–73) | 0.46 | 66 (59–74) | 66 (59–73) | 66 (59–74) | 0.11 | 0.27 |
| Sex | |||||||||
| Male | 657 (69.2) | 344 (69.3) | 313 (68.9) | 0.89 | 1238 (63.0) | 628 (62.4) | 610 (63.6) | 0.59 | <0.01 |
| Female | 293 (30.8) | 152 (30.6) | 141 (31.1) | 727 (37.0) | 378 (37.6) | 349 (36.4) | |||
| Current smoking | 325/942 (34.5) | 165/491 (33.6) | 160/451 (35.5) | 0.55 | 642/1950 (32.9) | 338/998 (33.9) | 304/952 (31.9) | 0.36 | 0.40 |
| Current drinking* | 190/941 (20.2) | 104/491 (21.2) | 86/450 (19.1) | 0.43 | 400/1950 (20.5) | 197/998 (19.7) | 203/952 (21.3) | 0.39 | 0.84 |
| Comorbidities† | |||||||||
| Hypertension | 448 (47.2) | 229 (46.2) | 219 (48.2) | 0.52 | 1362 (69.3) | 702 (69.8) | 660 (68.8) | 0.65 | <0.01 |
| Diabetes mellitus | 238 (25.1) | 115 (23.2) | 123 (27.1) | 0.17 | 504 (25.6) | 286 (28.4) | 218 (22.7) | <0.01 | 0.73 |
| Previous stroke‡ | 327/942 (34.7) | 176/490 (35.9) | 151/452 (33.4) | 0.42 | 612/1958 (31.3) | 306/1001 (30.6) | 306/957 (32.0) | 0.50 | 0.06 |
| Previous transient ischaemic attack | 5/943 (0.5) | 3/493 (0.6) | 2/450 (0.4) | 0.73 | 7/1951 (0.4) | 4/1000 (0.4) | 3/951 (0.3) | 0.76 | 0.50 |
| Blood pressure at randomisation, mm Hg | |||||||||
| Systolic | 132 (126–140) | 133 (127–140) | 131 (125–140) | 0.18 | 160 (151–176) | 160 (151–177) | 160 (151–176) | 0.10 | <0.01 |
| Diastolic | 80 (78–90) | 80 (77–90) | 80 (79–90) | 0.97 | 90 (86–100) | 92 (86–100) | 90 (85–100) | 0.08 | <0.01 |
| Blood glucose, mmol/L | 5.9 (5.1–7.7) | 5.9 (5.1–7.5) | 5.9 (5.1–8.1) | 0.89 | 6.1 (5.3–8.1) | 6.2 (5.3–8.1) | 6.1 (5.2–7.9) | 0.41 | <0.01 |
| Baseline NIHSS score§ | 4 (4-6) | 4 (4-6) | 5 (4-6) | 0.80 | 5 (4-6) | 5 (4-6) | 5 (4-6) | 0.87 | 0.04 |
| Estimated premorbid function (mRS)¶ | |||||||||
| No symptoms | 658 (69.3) | 334 (67.3) | 324 (71.4) | 0.40 | 1414 (72.0) | 722 (71.8) | 692 (72.2) | 0.38 | 0.26 |
| Symptoms without disability | 290 (30.5) | 161 (32.5) | 129 (28.4) | 549 (27.9) | 282 (28.0) | 267 (27.8) | |||
| Mild disability | 2 (0.2) | 1 (0.2) | 1 (0.2) | 2 (0.1) | 2 (0.2) | 0 (0.0) | |||
| Time from stroke onset to antiplatelet therapy, hours | 19.1 (8.2–26.0) | 18.6 (8.1–26.0) | 19.5 (8.3–26.1) | 0.75 | 16.8 (7.4–26.1) | 16.8 (7.1–26.0) | 16.9 (7.8–26.3) | 0.91 | 0.06 |
| Presumed stroke cause** | |||||||||
| Undetermined cause | 600/949 (63.2) | 306/495 (61.8) | 294 (64.8) | 0.44 | 1172/1961 (59.8) | 611/1004 (60.9) | 561/957 (58.6) | 0.28 | 0.18 |
| Small artery occlusion | 286/949 (30.1) | 160/495 (32.3) | 126 (27.8) | 612/1961 (31.2) | 294/1004 (29.3) | 318/957 (33.2) | |||
| Large artery atherosclerosis | 28/949 (6.3) | 28/495 (5.7) | 32 (7.0) | 165/1961 (8.4) | 91/1004 (9.1) | 74/957 (7.7) | |||
| Other determined cause | 2/949 (0.2) | 1/495 (0.2) | 1 (0.2) | 9/1961 (0.5) | 6/1004 (0.6) | 3/957 (0.3) | |||
| Cardioembolic | 1/949 (0.1) | 0/495 (0.0) | 1 (0.2) | 3/1961 (0.2) | 2/1004 (0.2) | 1/957 (0.1) | |||
| Location of responsible vessel (identified by circulation infarction) | |||||||||
| Anterior | 571/794 (71.9) | 303/425 (71.3) | 268/369 (72.6) | 0.88 | 1209/1713 (70.6) | 607/892 (68.0) | 602/821 (73.3) | <0.01 | 0.38 |
| Posterior | 195/794 (24.6) | 106/425 (24.9) | 89/369 (2.1) | 456/1713 (26.6) | 265/892 (29.7) | 191/821 (23.3) | |||
| Anterior and posterior | 16/794 (3.8) | 16/425 (3.8) | 12/369 (3.3) | 48/1713 (2.8) | 20/892 (2.2) | 28/821 (3.4) | |||
| Patients receiving hypertension treatment†† | 107 (11.3) | 62 (12.5) | 45 (9.9) | 0.21 | 541 (27.5) | 280 (27.8) | 261 (27.2) | 0.76 | <0.01 |
| Timing of starting treatment after admission, days | 0 (0–4) | 0 (0–4) | 0 (0–4) | 0.48 | 0 (0–2) | 0 (0–2) | 0 (0–2) | 0.52 | 0.73 |
| Patients receiving hyperglycaemia treatment‡‡ | 93 (9.8) | 45 (9.1) | 4 (10.6) | 0.44 | 223 (11.3) | 121 (12.0) | 102 (10.6) | 0.33 | 0.20 |
| Timing of starting treatment after admission, days | 0 (0–1) | 0 (0–1) | 0 (0–1) | 0.50 | 0 (0–1) | 0 (0–1) | 0 (0–2) | 0.47 | 0.43 |
The data were shown with median (IQR) for continuous characteristic or frequency (percentages) for categorical characteristic.
*Current drinker means consuming alcohol at least once a week within 1 year before onset of the disease and consuming alcohol continuously for more than 1 year.
†The comorbidities were based on the patient or family report.
‡Previous ischaemic stroke referred only to the patients with prestroke mRS≤1.
§Patients with NIHSS scores of 4–10 were eligible for this study; NIHSS scores range from 0 to 42, with higher scores indicating more severe neurological deficit.
¶Scores on the mRS of functional disability range from 0 (no symptoms) to 6 (death). No symptoms indicates scoring 0, symptoms without disability indicates scoring 1, and mild disability indicates scoring 2.
**The presumed stroke cause was classified according to the Trial of Org 10 172 in Acute Stroke Treatment classification system20 using clinical findings, brain imaging and laboratory tests. Other determined causes included pulmonary embolism, peripheral vessel incident and cardiovascular incident.
††Type of antihypertension drug included ACE inhibitors and angiotensin receptor blocker (106/648), beta receptor blocker (15/648), calcium channel blocker (479/648), diuretic (5/648) and others (43/648).
‡‡The population included 742 patients who were diagnosed with diabetes mellitus and 130 patients who were found hyperglycaemia at admission.
§§The p value represented the significance when compared between SBP<140 mm Hg and SBP≥140 mm Hg subgroups.
mRS, modified Rankin Scale; NIHSS, National Institute of Health Stroke Scale; SBP, systolic blood pressure.