30 results
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…
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.
-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 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…
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-…
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.
In order to set up paradigms for pharmaco-MRI studies for development of novel psychotropic medications. The present study will investigate the effect of: - low-dose benzodiazepine on brain activation and test performance on a testbed of well…
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 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
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…
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…
Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.Secundary:• To assess the safety and tolerability of VMX-C001 in a simulated emergency use setting.• To assess the…
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
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 .
Primary objective:• To assess, in healthy subjects, the pharmacodynamic (PD) properties of PCC in the presence and absence of selected DOACs.Secondary objectives:• To assess, in healthy subjects, the safety and tolerability of PCC in the presence…
The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss(>5% weight loss) after 22 weeks in patients with weight regain after bariatric surgery, compared to the regular…
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 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…
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…