21 results
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
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.
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…
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…
The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
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 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 (…
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…
To investigate the effect of dabigatran etexilate on airway inflammation, hemostasis and asthma control in patients with severe asthma.
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 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.
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 "…
See protocol sectie 2.1 & 2.2
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
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…
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…
To measure DOAC levels just before surgery of all DOAC patients in the LUMC with elective surgery for which ceasing of DOAC treatment is required.
To evaluate management strategies in premenopausal women with heavy menstrual bleeding associated with factor Xa inhibitor therapy.
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…