12 results
Dual Primary Objectives:* To determine if apixaban is noninferior to VKA (INR target range 2.0-3.0) on the combined endpoint of ISTHmajor or clinically relevant non-major bleeding in patients with NVAF who develop ACS or undergo PCI withplanned…
Primary objective:The primary objective of this study is to evaluate the effect of LCM 200mg bid on the single dose PK and PD of a single warfarin 25mg dose.Secondary objective:The secondary objective of this study is to monitor the safety and…
The goal of this trial is to collect long-term observational data on the tolerability, safety and efficacy of dabigatran etexilate in a spectrum of patients receiving bileaflet mechanical heart valves. All patients that have completed study 1160.113…
The purpose of this study is to confirm/validate predicted dabigatran trough plasma levels gained after individual dose assignment based on simulations by means of PK data from the RE-LY trial. Based on this validation a final appropriate dosing…
See section 2.2 of the protocol.The main objective of this study is to compare a DAT regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE-DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (…
Primary Objective: 1. To investigate the safety of cold plasma plaster treatment of diabetic foot ulcers. Secondary Objective(s): 1. To investigate the effect of cold plasma plaster treatment of diabetic foot ulcers on bacterial load.2. To…
See protocol sectie 2.1 & 2.2
See section 2.2. of the protocol.The primary objective of this trial is to assess the safety of an uninterrupted dabigatran etexilate periprocedural anticoagulant regimen compared to an uninterrupted warfarin regimen in NVAF patients undergoing AF…
Primary: To assess the effect of multiple doses of tasqinimod on the single-dose pharmacodynamics (PD) of warfarin. Secondary: To assess the effect of multiple doses of tasqinimod on the single-dose pharmacokinetics (PK) of warfarin. To assess the…
The primary objective of this study is to demonstrate that the efficacy of rivaroxaban, a direct FXa inhibitor, is non-inferior to that of dose-adjusted warfarin for the prevention of thromboembolic events in subjects with non-valvular atrial…
The main purpose of this study is to investigate the effect of nipocalimab on how quickly and to what extent etanercept or hydroxychloroquine is absorbed, distributed, metabolized and eliminated from the body. The study consists of 2 parts, Part 1…
In this study we will investigate how safe the new compound nipocalimab is and how well it is tolerated when it is used by healthy participants.We also investigate how quickly and to what extent nipocalimab is absorbed, transported, and eliminated…