24 results
Objectives:To collect data on effect size for, and determine the feasibility of, a full scale multicentre RCT(Randomized Controlled Trial) that1. compares the efficacy and safety of NOACs with VKA treatment according to Dutchstandards, in VKA-…
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…
To determine whether a single dose of 50 IE/Kg PCC is effective in reversing the anticoagulant effect of Dabigatran Etexilate 300mg b.i.d. taken for 2.5 days, as assessed by two modified skin bleeding assays: the "shed blood" and "…
To investigate whether oral administration of dabigatran etexilate in patients with a rhegmatogenous retinal detachment leads to clinical significant dabigatran levels and thrombin inhibiting activity in the vitreous and subretinal fluid.
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…
The aim of this phase I study is to assess the extent of intestinal absorption of rivaroxaban and dabigatran etexilate in adult patients with short bowel syndrome and treated with long-term TPN.
To asses the comparability of the estimated dabigatran concentration in plasma via calibrated Hemoclot and the measured dabigatran concentrations assessed in a central lab in patients with moderate renal impairment undergoing primary unilateral…
Study questionWhat is the effect of a single administration of prothrombin complex concentrate (CoFact) on the anticoagulant effect of a novel oral thrombin inhibitor (Dabigatran) and a novel oral factor Xa inhibitor (Rivaroxaban) in healthy human…
Objective: The aim of this study is to investigate the in-vivo variability of hemostasis between patients when treated with a direct thrombin inhibitor (Dabigatran) or a direct Factor Xa (FXa) inhibitor (Rivaroxaban) by measuring thrombin generation…
To provide single dose PK/PD dataTo investigate tolerability and safety of dabigatran etexilate solution in children1 to <12 years of age
To investigate the effect of dabigatran etexilate on airway inflammation, hemostasis and asthma control in patients with severe asthma.
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
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 (…
To determine whether [18F]FES PET/CT improves staging for women with clinical stage II/III or LRR, ER+ breast cancer as compared to standard [18F]FDG PET/CT.
- part A: to identify the pharmacokinetic model that represents the [18F]FES kinetics most optimally and to validate simplified quantitative parameters of [18F]FES uptake. - part B: to investigate the repeatability of simplified quantitative…
The primary objectives of this study are to:* Determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of oral BAY 1217389 given in combination with intravenous (IV) paclitaxel using an intermittent…
The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
See protocol sectie 2.1 & 2.2
A real world registry to compare dual therapy with Dabigatran/Clopidogrel to Usual care (Triple Therapy) with Dabigatran/Clopidogrel/Aspirin in patients with an indication for NOAC undergoing PCI in the setting of ACS. Hypothesis: Dual therapy with…