20 results
The primary objective of this investigation is to evaluate the performance of the DISCOVER Artificial Cervical Disc in the treatment of cervical disc disease by measuring the function assessed via Neck Disability Index (NDI) and neurological…
The primary efficacy objective of this study is to:* Compare the incidences of the composite endpoints of stroke, systemic embolic event (SEE), myocardial infarction (MI) and cardiovascular (CV) mortality between the edoxaban group and the…
The primary objective of this investigation is to evaluate the performance of the DISCOVER Artificial CervicalDisc in the treatment of cervical disc disease by measuring the function assessed via Neck Disability Index(NDI) and neurological function…
The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH compared with dalteparin for theprevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects…
Primary efficacy objective:To compare descriptively the incidence of the composite of all-cause death, stroke (ischemic, hemorrhagic, or undetermined) and MajorBleeding (International Society on Thrombosis and Hemostasis [ISTH] definition) in the…
The primary objective is to test whether thrombolysis with additional contrast-enhanced ultrasound is applicable in patients with peripheral arterial occlusions. The secondary objectives are to investigate the safety of microbubble and ultrasound…
The primary objective is to compare a 12-month antithrombotic regimen of edoxaban in combination with clopidogrel or another P2Y12 antagonist against a regimen of a vitamin K antagonist (VKA) in combination with clopidogrel or another P2Y12…
The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
Primary Objective: To assess the ex-vivo anticoagulant potency of Edoxaban in patients with Child Pugh A/B cirrhosis, by means of percentual changes in ex-vivo thrombin generation from baseline compared to steady state. These results will be…
To compare the plasma concentration of edoxaban in women with breast cancer before and during treatment with tamoxifen.
The primary objective is to demonstrate the non-inferiority of edoxaban to standard of care (SOC; including low molecular weight heparin (LMWH), or vitamin K antagonist (VKA)) in the treatment and secondary prevention of VTE in pediatric subjects…
* To assess the effect of Edoxaban versus vitamin K antagonist (VKA) on net adverse clinical events (NACE), i.e., the composite of all-cause death, myocardial infarction (MI), ischemic stroke, systemic thromboembolism (SEE), valve thrombosis, and…
To investigate whether treatment with edoxaban leads to a decrease in incidence of leaflet thickening and is clinical efficient and safe.
The objective of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics. This information is urgently needed to optimize the treatment of patients with prostate cancer using enzalutamide and facilitate the…
To demonstrate that oral anticoagulation with the NOAC edoxaban is superior to current therapy (antiplatelet therapy or no therapy depending on cardio-vascular risk) to prevent stroke, systemic embolism, or cardiovascular death in patients with AHRE…
To evaluate the safety and efficacy of DOAC versus VKA in CTEPH/CTED patients receiving BPA, based on the composite endpoint of periprocedural bleeding (life-threatening or disabling bleeding, vascular injury or access site problems) and lung injury…
Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.Secundary:• To assess the safety and tolerability of VMX-C001 in a simulated emergency use setting.• To assess the…
Primary objective:• To assess, in healthy subjects, the pharmacodynamic (PD) properties of PCC in the presence and absence of selected DOACs.Secondary objectives:• To assess, in healthy subjects, the safety and tolerability of PCC in the presence…
1. To compare bleeding risk (i.e. safety) with DAPT compared to standard therapy during the first 30 days following PCI/ACS in patients with AF2. To compare ischemic risk (i.e. efficacy) with DAPT compared to standard therapy during the first 30…
The primary objective is to evaluate whether the impact of a strategy aimed at switching INR-guided VKA management to a NOAC-based treatment strategy is superior in terms of the occurrence of major or clinically relevant non-major bleeding…