Table 1

Baseline clinical, angiographic and procedural characteristics

Full analysis set (N=585)Per-protocol set (N=169)P values*
Danegaptide high
(n=184)
Danegaptide low
(n=206)
Placebo
(n=195)
Danegaptide high
(n=57)
Danegaptide low
(n=60)
Placebo
(n=52)
Age (years)60.5±11.660.0±11.161.0±10.957.0±10.557.3±9.156.0±9.70.776
BMI (kg/m2)27.3±3.826.9±4.127.4±4.327.7±4.626.8±4.327.6±4.20.560
Male145 (78.8)160 (77.7)146 (74.9)46 (80.7)47 (78.3)45 (86.5)0.509
Current smokers83 (45.1)87 (42.2)80 (41.0)34 (59.6)20 (33.3)17 (32.7)0.005
Killip Class I178 (96.7)198 (96.6)192 (98.5)56 (98.2)60 (100.0)52 (100.0)0.645
Diabetes mellitus16 (8.7)22 (10.7)23 (11.8)4 (7.0)5 (8.3)6 (11.5)0.747
Family history of IHD70 (38.0)82 (39.8)79 (40.5)24 (42.1)27 (45.0)24 (46.2)0.924
History of stroke5 (2.7)7 (3.4)12 (6.2)3 (5.3)0 (0.0)3 (5.8)0.142
Hypercholesterolaemia31 (16.8)28 (13.6)35 (17.9)7 (12.3)11 (18.3)4 (7.7)0.265
Hypertension70 (38.0)61 (29.6)79 (40.5)24 (42.1)13 (21.7)15 (28.8)0.054
Symptoms to first medical contact time (h)0.9 (0.0–10.6)0.9 (0.0–9.8)1.0 (0.0–31.2)0.8 (0.0–4.3)0.9 (0.0–4.1)1.0 (0.0–4.2)0.721
First medical contact to hospital arrival (h)1.1 (0.2–4.3)1.1 (0.0–22.3)1.2 (0.1–4.0)1.0 (0.2–4.3)1.0 (0.4–2.2)1.0 (0.3–4.0)0.747
Door-to-balloon time (h)0.5 (0.2–1.9)0.5 (0.2–2.6)0.5 (0.2–3.0)0.5 (0.2–1.9)0.4 (0.3–2.6)0.5 (0.3–1.6)0.400
Bolus IMP to first wire (h)0.3 (0.1–1.3)0.3 (0.1–1.2)0.3 (0.2–0.9)0.3 (0.2–0.8)0.3 (0.2–0.6)0.3 (0.2–0.8)0.135
Total ischaemic time (h)2.6 (1.2–12.7)2.6 (0.7–10.0)2.7 (1.2–32.7)2.4 (1.2–5.8)2.4 (1.3–5.9)2.8 (1.2–5.9)0.626
 Total ischaemic time <2 houra38 (23.2)41 (21.8)35 (19.1)13 (22.8)15 (25.0)12 (23.1)0.464
 Total ischaemic time 2–<3 hours62 (37.8)74 (39.4)70 (38.3)28 (49.1)23 (38.3)16 (30.8)
 Total ischaemic time 3–<4 hours23 (14.0)32 (17.0)32 (17.5)7 (12.3)13 (21.7)13 (25.0)
 Total ischaemic time 4–<6 hours29 (17.7)27 (14.4)32 (17.5)9 (15.8)9 (15.0)11 (21.2)
 Total ischaemic time >6 hours12 (7.3)14 (7.4)14 (7.7)0 (0.0)0 (0.0)0 (0.0)
Left anterior infarct76 (41.3)80 (38.8)83 (42.6)26 (45.6)26 (43.3)28 (53.8)0.820
Left circumflex infarct22 (12.0)23 (11.2)35 (17.9)5 (8.8)7 (11.7)4 (7.7)
Right coronary infarct68 (37.0)86 (41.7)70 (35.9)26 (45.6)27 (45.0)20 (38.5)
Collateral flow (Rentrop grade 2/3)9 (4.9)9 (4.4)11 (5.6)2 (3.5)5 (8.3)1 (1.9)0.310
TIMI grade 3 after procedure156 (95.7)183 (96.8)179 (97.8)56 (98.2)60 (100.0)50 (96.2)0.204
Thrombectomy70 (41.7)76 (40.2)82 (43.6)28 (49.1)29 (48.3)26 (50.0)1.000
Stent implantation151 (89.9)168 (88.9)169 (89.9)56 (98.2)58 (96.7)52 (100.0)0.775
Medical therapy at discharge
 ACE inhibitor66 (36)76 (37)72 (37)
 Beta blocking agents178 (97)193 (94)195 (100)
 Acetylsalicylic acid184 (100)205 (100)195 (100)
 Clopidogrel21 (11)20 (10)26 (13)
 Prasugrel53 (29)76 (37)68 (35)
 Ticagrelor104 (57)107 (52)98 (50)
 Statins176 (96)196 (95)190 (97)
  • Data are presented as mean±SD, median (range) or N (%), unless otherwise indicated.

  • *P values for test of equality across treatment arms in the PP set are derived from the Wilcoxon test or Fisher’s exact test.

  • BMI, body mass index; h, hours; IHD, ischaemic heart disease; IMP, investigational medicinal product; N, number of patients; TIMI, thrombolysis in myocardial infarction.