Table 1.
Placebo | JNJ-9375 (2.5 μg/mL) | JNJ-9375 (25 μg/mL) | JNJ-9375 (250 μg/mL) | Bivalirudin (6 μg/mL) | |
---|---|---|---|---|---|
PT (s) | 13.7 (10.5, 16.9) | 13.9 (10.7, 17.1) | 15.8 (12.6, 19.0) | 30.0 (26.8, 33.2) | 36.6 (33.4, 39.8) |
APTT (s) | 28.9 (23.3, 34.6) | 31.4 (25.7, 37.0) | 41.6 (35.9, 47.3) | 63.5 (57.8, 69.2) | 91.5 (85.8, 97.2) |
TT (s) | 15.6 (−12.7, 43.8) | 24.9 (−3.3, 53.2) | 80.9 (52.6, 109.2) | 245.6 (217.3, 273.9) | 351.2 (323.0, 379.5) |
Dilute TT (s) | <LLOQ | <LLOQ | <LLOQ | 151.5 (126.5, 176.6) | >501a |
P-Selectin GMFI | |||||
Unstimulated | 4.6 (3.6, 5.6) | 3.9 (2.9, 4.9) | 3.7 (2.7, 4.7) | 3.9 (2.9, 4.9) | 3.2 (2.2, 4.2) |
ADP 20 μM | 17.8 (11.6, 24.0) | 12.1 (6.0, 18.1) | 17.8 (11.9, 23.8) | 15.6 (9.7, 21.6) | 15.3 (9.4, 21.2) |
Thrombin 0.1 U/mL | 161.6 (100.3, 222.8) | 86.5 (28.0, 145.0) | 7.8 (−53.5, 69.1) | 1.6 (−62.8, 65.9) | −1.6 (−59.6, 56.3) |
PMA GMFI | |||||
Unstimulated | 33.0 (20.6, 45.4) | 35.6 (24.0, 47.3) | 27.6 (15.9, 39.3) | 25.0 (13.3, 36.7) | 25.0 (13.3, 36.7) |
ADP 20 μM | 48.9 (28.2, 69.5) | 54.9 (35.8, 73.9) | 48.5 (30.1, 67.0) | 50.1 (31.7, 68.6) | 46.4 (28.0, 64.8) |
Thrombin 0.1 U/mL | 401.0 (180.3, 621.6) | 414.6 (193.3, 635.8) | 175.3 (−45.7, 396.3) | 120.7 (−99.5, 340.9) | 85.0 (−123.2, 293.3) |
Total thrombus area (μm2/mm) | |||||
Low shear | 9571 (7669, 11 945) | 10 283 (8239, 12 834) | 8936 (7161, 11 153) | 5640 (4519, 7039) | 3318 (2659, 4141) |
High shear | 14 367 (10 734, 19 229) | 12961 (9684, 17 347) | 13 898 (10 384, 18 602) | 9729 (7269, 13 022) | 6312 (4716, 8448) |
Platelet-rich thrombus area (μm2/mm) | |||||
Low shear | 1255 (834, 1889) | 1610 (1055, 2456) | 1117 (742, 1681) | 1200 (798, 1806) | 832 (545, 1269) |
High shear | 7302 (4790, 11 131) | 5844 (3834, 8909) | 6405 (4202, 9763) | 5463 (3584, 8327) | 4111 (2697, 6267) |
Fibrin-rich thrombus area (μm2/mm) | |||||
Low shear | 10 349 (7535, 14 212) | 10 634 (7651, 14 782) | 9865 (7183, 13 547) | 4190 (3051, 5755) | 1162 (836, 1616) |
High shear | 9598 (7997, 11 521) | 9176 (7645, 11 014) | 8100 (6749, 9722) | 4625 (3854, 5552) | 1776 (1480, 2132) |
Data shown are means with 95% confidence intervals.
ADP, adenosine diphosphate; APTT, activated partial thromboplastin time; GMFI, geometric mean fluorescent intensity; LLOQ, less than lower limit of quantification; PT, prothrombin time; TT, thrombin time.
14 of 15 results >501 s.