Key result
ZK-807834 dose-dependently reduces ex-vivo arterial thrombus size by ~68% vs placebo in CAD patients.
Why the study?
Does direct factor-Xa inhibition with ZK-807834 reduce ex-vivo arterial thrombus formation in patients with stable coronary artery disease?
Population
18 patients with stable coronary artery disease, mean age 59 +/- 9 years, 55% male
Comparison
24-hour infusion of direct factor-Xa inhibitor… vs Placebo infusion
Design
RCT, Randomized to four groups, Blindly randomized
Follow-up
8 hours post end-of-infusion
Authors
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Supports direct FXa inhibition for antithrombotic effect in CAD; extends RCT surrogate data and informs outcome trials.
RCT (n=18)
blindly
randomized
Does direct factor-Xa inhibition with ZK-807834 reduce ex-vivo arterial thrombus formation in patients with stable coronary artery disease?
Absolute Event Rate: 68% vs 0%
p-value: p=<0.001
Direct factor-Xa inhibition with ZK-807834 dose-dependently reduces ex-vivo arterial thrombus formation and factor-X activity in patients with coronary artery disease.
Osende et al. (2007) conducted an RCT in Coronary artery disease (n=18). ZK-807834 vs. Placebo was evaluated on Mean percent-reduction in thrombus size from baseline to end-of-infusion (p=<0.001). ZK-807834 dose-dependently reduced ex-vivo arterial thrombus size by up to 68% at end-of-infusion compared to placebo in patients with coronary artery disease (p<0.001).
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