50 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 assess the normalization (reversal) of coagulation assays upon administration of two dosages of Prothrombin Complex Concentratre (PCC, Cofact®) in healthy volunteers treated with either rivaroxaban or apixaban
The objective of this study is to demonstrate (1) the superior efficacy of VTE prophylaxis with oral rivaroxaban 10 mg once daily administered for 35 ± 4 days to SC enoxaparin 40 mg once daily (OD) administered for 10 ± 4 days in men and women aged…
The primary objective of the study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular (CV) death, myocardial infarction (MI), or stroke in subjects with a recent ACS compared with…
For the Einstein-DVT evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) without symptomatic…
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 aim of this study is to assess whether rivaroxaban, as compared to UFH, on the background of standard dual antiplatelet therapy (DAPT), can effectively suppress thrombosis, and related adverse ischemic events, upon balloon inflation and stent…
There are two phases in this trial with 2 objectives:In phase I of the trial it will be assessed which dose of rivaroxaban is the most safe and effective (most optimal benefit:risk profile). In phase II this dose will be further investigated to…
Uspio enhanced MRI (MRL) potentially has the ability to show all lymph nodes and hence provide information on metastasis in all nodes, this is in contrast with SLNB which only provides information on 1 (or a few) lymph node(s). With MRL metastases…
To examine the influence of genetic predisposition, genetic factors, infections and lifestyle of mother and child in relation to 1) allergic diseases and childhood astma;2) childhood overweight and obesity; 3) cardiopulmonary fitness and…
The purpose of this study is to show that the incidence of new thrombotic events during an additional 6 or 12 months of treatment with rivaroxaban is lower when compared to placebo and that the likely advantage of an extended effect is not offset by…
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…
The purpose of this study is to demonstrate that in patients with DVT or PE who use a strong CYP 3A4 inducer, the use of this higher rivaroxaban dose results in a similar rivaroxaban concentration in the blood and a rivaroxaban induced blood…
Primary objectives:- To identify whether EBC can be used as a non-invasive method to measure the PK of salbutamol and tobramycin.- To determine whether the relationship in mild-moderate asthmatics between pulmonary lung function parameters and…
Primary:To compare the effect of 6 months use of the CIS on adherence to ELLIPTA maintenance therapy when both the subject and the HCP are supplied with data from the maintenance sensor versus no data supplied to the subject and HCP (Arm 1 vs Arm 5…
To study the effectiveness of low-dose rivaroxaban with aspirin in improving endothelial function in patients with symptomatic or stable PAD.
To demonstrate elevation in immune responsiveness to LPS stimulation when switching from ASA to DPI in patients with CAD, and to further explore whether changes in monocyte function and epigenetic landscape are responsible for the observed…
The primary objectives of this study are:Part A 1. To characterize the effects of single doses of beta-adrenoceptor (*-AR) agonists CST-101, CST-103 and * AR partial agonist CST-109 on the functional domains of the central nervous system (CNS), as…
To estimate the bleeding risk with rivaroxaban, compared with ASA, in addition to a singleantiplatelet agent (clopidogrel or ticagrelor), in subjects with a recent ACS .
The primary efficacy objective is to assess the incidence of symptomatic recurrent venous thromboembolism.The secondary efficacy objective is to assess the incidence of symptomatic recurrent venous thromboembolism and asymptomatic deterioration on…