Key result
JNJ-9375 (250 μg/mL) reduced mean total thrombus area by 41.1% (95% CI 22.3-55.3%; P<0.001) at low shear and 32.3% (95% CI 4.9-51.8%; P=0.025) at high shear compared to placebo.
Why the study?
Does JNJ-64179375 reduce thrombus formation and platelet activation in an ex vivo human translational model of thrombosis?
Population
15 healthy volunteers
Comparison
JNJ-64179375 (JNJ-9375) at 2.5, 25, and 250 μg/mL vs Bivalirudin and matched placebo
Design
RCT, randomized crossover, double-blind
Authors
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Supports antithrombotic development of JNJ-64179375; extends RCT evidence to human ex vivo thrombosis models.
RCT (n=15)
Double-blind
crossover
Does JNJ-64179375 reduce thrombus formation and platelet activation in an ex vivo human translational model of thrombosis?
Effect estimate: 41.1% reduction (95% CI 22.3 to 55.3)
p-value: p=< 0.001
JNJ-64179375, a novel exosite 1 thrombin inhibitor, successfully prolonged blood coagulation and reduced ex vivo thrombosis in healthy volunteers, primarily by decreasing fibrin-rich thrombus formation.
Wilson et al. (2018) conducted an RCT in healthy volunteers (n=15). JNJ-64179375 (JNJ-9375) vs. bivalirudin (6 μg/mL) and matched placebo was evaluated on mean total thrombus area at low shear (41.1% reduction, 95% CI 22.3 to 55.3, p=< 0.001). JNJ-9375 (250 μg/mL) reduced mean total thrombus area by 41.1% (95% CI 22.3-55.3%; P<0.001) at low shear and 32.3% (95% CI 4.9-51.8%; P=0.025) at high shear compared to placebo.
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