Key result
Terutroban significantly decreased the mean cross-sectional surface of dense thrombus by 58% over 10 days, which was significantly lower than aspirin alone (p<0.01).
Why the study?
Does terutroban improve antithrombotic and antiplatelet activity compared to aspirin or clopidogrel+aspirin in patients with prior cerebral ischemic events or carotid stenosis?
RCT (n=48)
Double-blind
Does terutroban improve antithrombotic and antiplatelet activity compared to aspirin or clopidogrel+aspirin in patients with prior cerebral ischemic events or carotid stenosis?
p-value: p=<0.01
Terutroban demonstrates superior antithrombotic activity to aspirin and similar activity to clopidogrel plus aspirin in patients with prior ischemic stroke or carotid stenosis.
Supports terutroban evaluation in outcome trials for secondary stroke prevention; extends RCT evidence on antithrombotic effects versus aspirin.
BACKGROUND: The antithrombotic, antiplatelet and endothelial activity of terutroban, a specific thromboxane prostaglandin receptor antagonist, was assessed in patients previously treated with aspirin for the prevention of ischemic stroke. METHODS: This double-blind, parallel-group, 10-day study included 48 patients (age = 70.5 +/- 9.5 years) with cerebral ischemic event and/or carotid stenosis in 4 groups: terutroban 10 mg/day (n = 13), aspirin 300 mg/day (n = 12), terutroban 10 mg/day + aspirin 300 mg/day (n = 11) or clopidogrel 75 mg/day + aspirin 300 mg/day (n = 12). The measurements included parameters from an ex vivo model of thrombosis, platelet aggregation in platelet-rich plasma and plasma biomarkers of endothelial/platelet activation. RESULTS: Between days 0 and 10, the mean cross-sectional surface of dense thrombus significantly decreased with terutroban (58%, p = 0.001), terutroban + aspirin (63%, p = 0.005) and clopidogrel + aspirin (61%, p < 0.05). On day 10, the value for terutroban was significantly lower than that for aspirin (p < 0.01) and was comparable to the dual therapy terutroban + aspirin or clopidogrel + aspirin. Similar results were found for total thrombus surface and platelet adhesion. Platelet aggregation induced by the specific thromboxane prostaglandin receptor agonist U46619 was almost completely inhibited on day 10 in both terutroban groups but not in the others. As regards markers of endothelial/platelet activation or lesions, thrombomodulin significantly increased and plasma soluble P selectin significantly decreased by day 10 in both terutroban groups, whereas the von Willebrand factor did not change significantly. Terutroban was found to be safe and well TOLERATED. CONCLUSIONS: Terutroban has demonstrated an antithrombotic activity that is superior to aspirin and similar to clopidogrel + aspirin; it induces a significant in vivo reduction in endothelial/platelet activation.
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Sollier et al. (2009) conducted an RCT in Cerebral ischemic event and/or carotid stenosis (n=48). Terutroban vs. Aspirin 300 mg/day was evaluated on Mean cross-sectional surface of dense thrombus (p=<0.01). Terutroban significantly decreased the mean cross-sectional surface of dense thrombus by 58% over 10 days, which was significantly lower than aspirin alone (p<0.01).
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