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Published on: October 12, 2012
Antithrombotic effects of DX-9065a, a direct factor Xa inhibitor: a comparative study in humans versus low molecular
Daichi Shimbo1, Julio Osende, Julie Chen
1Cardiovascular Biology Research Laboratory, Mount Sinai School of Medicine, New York, NY 10029, USA.
Background:
Recent evidence suggests that TF may play a causal role in acute coronary syndromes, and may be an important therapeutic target. Several inhibitors of TF, coagulation factors VIIa and Xa are under investigation as novel antithrombotic approaches. We compared the antithrombotic effects of DX-9065a, a new FXa inhibitor, vs. enoxaparin.
Methods And Results:
The protocol was an open-label crossover study. Subjects (n = 6) participated in 3 consecutive study-arms: a) enoxaparin + ASA (1 mg/Kg s. c + 162 mg/day x 3 days), b) three escalating doses of DX-9065a (1 mg bolus + 0.25 mg/h x 2 h, followed by an additional 1 mg bolus + 0.625 mg/h x 2 h and, a final 1 mg bolus + 1.25 mg/h x 2 h), and c) the same doses of DX-9065a in Arm 2 plus ASA pre-treatment. The antithrombotic effects were assessed using the Badimon perfusion chamber at each dose level. The administration of DX-9065a whether alone or combined with ASA significantly inhibited thrombus formation at high and low shear rate conditions while enoxaparin did not have a significant effect. Furthermore, these antithrombotic effects were obtained without significant prolongations of the standard coagulation parameters as those induced by enoxaparin.
Conclusions:
The direct inhibition of FXa by DX-9065a appears to be a safe and effective new approach for preventing the thrombotic complications of atherosclerotic disease. The clinical effectiveness of the direct FXa inhibitors should be further investigated.
Insights
Directly inhibiting Factor Xa (FXa) with DX-9065a effectively prevented thrombus formation in atherosclerotic disease models. This novel antithrombotic approach showed superior efficacy compared to enoxaparin without significantly altering coagulation parameters.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Thrombosis Research
Background:
- Tissue Factor (TF) is implicated in acute coronary syndromes.
- TF inhibitors and coagulation factor inhibitors are novel antithrombotic strategies.
- DX-9065a is a novel FXa inhibitor investigated for antithrombotic effects.
Purpose of the Study:
- To compare the antithrombotic effects of DX-9065a versus enoxaparin.
- To evaluate DX-9065a's efficacy alone and in combination with aspirin (ASA).
Main Methods:
- Open-label, crossover study with 6 subjects.
- Three study arms: enoxaparin + ASA, escalating doses of DX-9065a, and DX-9065a + ASA.
- Antithrombotic effects assessed using the Badimon perfusion chamber.
Main Results:
- DX-9065a significantly inhibited thrombus formation at high and low shear rates.
- Enoxaparin did not show a significant antithrombotic effect.
- DX-9065a's effects were achieved without significant prolongation of standard coagulation parameters.
Conclusions:
- Direct FXa inhibition by DX-9065a is a safe and effective strategy for preventing thrombotic complications in atherosclerotic disease.
- Further investigation into the clinical effectiveness of direct FXa inhibitors is warranted.
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