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A prospective, randomised, open-label, blinded endpoint evaluation (PROBE) parallel group study comparing edoxaban (DU-176b) with enoxaparin/warfarin followed by warfarin alone in subjects undergoing planned electrical cardioversion of nonvalvular atrial fibrillation

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 effect of body weight on trough concentrations of DOACs in patients.

The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®

A PROSPECTIVE, RANDOMIZED, OPEN-LABEL, BLINDED ENDPOINT EVALUATION (PROBE) PARALLEL GROUP STUDY COMPARING EDOXABAN VS. VKA IN SUBJECTS UNDERGOING CATHETER ABLATION OF NON-VALVULAR ATRIAL FIBRILLATION

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…

A Phase 3b, prospective, randomized, open-label, blind evaluator (PROBE) study evaluating the efficacy and safety of LMWheparin/edoxaban versus dalteparin in venous thromboembolism associated with cancer

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…

A Phase 3, open-label, randomized, multi-center, controlled trial to evaluate the pharmacokinetics and pharmacodynamics of edoxaban and to compare the efficacy and safety of edoxaban with standard of care anticoagulant therapy in pediatric subjects from birth to less than 18 years of age with confirmed venous thromboembolism (VTE)

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…

The ex-vivo potency of Edoxaban in patients with cirrhosis

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…

Evaluation of the safety and efficacy of an edoxaban-based compared to a vitamin K antagonist- based antithrombotic regimen following successful percutaneous coronary intervention (PCI) with stent placement (ENTRUST_AF PCI)

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…

Rotterdam Edoxaban Leaflet Evaluation in Patients after Transcatheter Aortic Valve Implantation

To investigate whether treatment with edoxaban leads to a decrease in incidence of leaflet thickening and is clinical efficient and safe.

A pharmacokinetic study of edoxaban in patients with breast cancer using the P-glycoprotein inhibitor tamoxifen

To compare the plasma concentration of edoxaban in women with breast cancer before and during treatment with tamoxifen.

Edoxaban Versus Standard of Care and Their Effects on Clinical Outcomes in Patients Having Undergone Transcatheter Aortic Valve Implantation * In Atrial Fibrillation.

* 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…

An Open-Label Study to Assess the Effects of VMX-C001 in Combination with an Oral FXa DOAC on the Efficacy of Unfractionated Heparin in Healthy Subjects.

This study has been transitioned to CTIS with ID 2024-514339-87-00 check the CTIS register for the current data. Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.…

Anticoagulant medicines for Balloon Pulmonary Angioplasty

This study has been transitioned to CTIS with ID 2024-518803-23-00 check the CTIS register for the current data. To evaluate the safety and efficacy of DOAC versus VKA in CTEPH/CTED patients receiving BPA, based on the composite endpoint of…

Determining the clinical relevance of the interaction between enzalutamide and the opioid morphine and the DOAC edoxaban to improve rational pharmacological care of patients with prostate cancer

This study has been transitioned to CTIS with ID 2024-517646-34-00 check the CTIS register for the current data. The objective of this study is to evaluate the effect of enzalutamide on morphine and edoxaban pharmacokinetics. This information is…

What is the optimal antithrombotic strategy in patients with atrial fibrillation having acute coronary syndrome or undergoing percutaneous coronary intervention?

This study has been transitioned to CTIS with ID 2022-502140-13-00 check the CTIS register for the current data. 1. To compare bleeding risk (i.e. safety) with DAPT compared to standard therapy during the first 30 days following PCI/ACS in patients…

Switching anticoagulant management from a VKA to a NOAC-based tratment strategy in frail elderly patients with atrial fibrillation

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…