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Japanese-based pharmaceutical firm Daiichi Sankyo has begun enrolment in the Phase IIIb ENTRUST-AF PCI clinical trial of edoxaban for the treatment of atrial fibrillation patients who have undergone percutaneous coronary intervention (PCI) with stent placement.
Edoxaban is an oral, once-daily, direct factor Xa inhibitor designed to make the blood thin and minimise its clotting.
The firm plans to enrol 1,500 patients from 200 clinical sites across countries such as Europe, Korea, Taiwan and Ukraine.
The prospective, randomised, open-label, blinded endpoint evaluation parallel-group Phase IIIb trial will assess the efficacy and safety of once-daily edoxaban compared to a vitamin K antagonist, in terms of incidence of major or clinically relevant non-major ISTH-defined bleeding (MCRB).
Daiichi Sankyo global medical affairs executive director Hans Lanz said: "ENTRUST-AF PCI will add to the growing body of evidence in the Edoxaban Clinical Research Programme, and the results will advance clinicians' understanding of the potential to reduce the risk of bleeding in atrial fibrillation patients undergoing PCI procedures."
The trial will evaluate edoxaban as part of a dual anti-thrombotic treatment strategy.
The patients will be administered a 12-month antithrombotic regimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist, or a regimen of a vitamin K antagonist in combination with clopidogrel or another P2Y12 antagonist and 1-12 months ASA.
Edoxaban is currently marketed in Japan, the US, South Korea, Hong Kong, Taiwan, as well as European countries such as Switzerland, the UK, Germany, Ireland, the Netherlands, Italy, Spain, Belgium, Austria and Portugal.
Image: Daiichi Sankyo initiates ENTRUST-AF PCI trial of once-daily edoxaban in patients with atrial fibrillation. Photo: courtesy of Daiichi Sankyo Company.