33 results
Primary Objective:To evaluate the efficacy and safety of 2 doses of benralizumab in patients with moderate to very severe Chronic Pulmonary Disease (COPD).Secondary Objectives:To evaluate the effect of two doses of benralizumab on:* health status/…
The primary efficacy objective of the study is:* to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducingthe risk of major thrombotic vascular events (defined as MI, ischemic stroke, CVdeath, ALI, and major amputation of a…
- Assess the incidence of major bleeding and clinically relevant non-major bleeding- Assess the incidence of recurrent venous thromboembolism- Assess the asymptomatic deterioration in the thrombotic burden on repeat imaging- Characterize the…
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 purpose of the study is to test whether a centre-wide policy of incremental antibiotic therapy will reduce arrhythmia device infection in patients undergoing arrhythmia device procedures compared to a policy of conventional antibiotic…
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-…
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 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…
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…
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…
With this study we will investiagate the superiority of fecal clysma therapy (n=34 patients) above conventional therapy with the antibiotic vancomycin (n=34 patients) or bowellavage with conventional antibiotic therapy (n=34 patients).
The following hypotheses will be tested:Hypothese a: Remifentanil PCA gives a better labour satisfaction than pethidine/meperidine i.m.Hypothese b: Remifentanil PCA gives a better pain-relief during labour, than pethidine/meperidine intramuscularly.…
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.
-Assess the incidence of major bleeding and clinically relevant non-major bleeding -Assess the incidence of recurrent venous thromboembolism -Characterize the pharmacokinetic/ pharmacodynamic profile of a 30-day treatment with oral rivaroxaban
The primary objective is to demonstrate the non-inferiority of rivaroxaban 10 mg versus enoxaparin 4000 IU relevant to the occurrence of major VTEs up until the end of the treatment (for example, cast or splint removal). The power of the study…
The primary objective is:- to characterize the pharmacokinetic/pharmacodynamic profile of a 7-day treatment with oral rivaroxabanThe secondary objectives are:- to assess the incidence of major bleeding and clinically relevant non-major bleeding- to…
The primary objective is to demonstrate that rivaroxaban is superior to placebo in subjects with chronic HF and significant CAD, who are receiving standard care, in reducing the risk of the composite of ACM, MI, or stroke following a recent…
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
In this study, the main clinical hypothesis is that the TIMI clinically significant bleeding rates will not be different between the rivaroxaban and VKA treatment strategy groups at Month 12.
To study the effectiveness of low-dose rivaroxaban with aspirin in improving endothelial function in patients with symptomatic or stable PAD.