10 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…
Primary objective: The primary objective of the study is to determine the effects of GM-CSF/IFN-γ on the in vivo immunoparalysis induced by human endotoxemia. This will be determined by measuring plasma levels of various pro and anti-inflammatory…
The primary aim of this pilot-study is to assess safety and the effects on immune function in patients with septic shock of adjunctive therapy with IFN-gamma, in a placebo-controlled manner. The data obtained will allow us to do a powercalculation…
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
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…
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 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 aim of ImmunoSep is to study if personalized immunotherapy targeting either fulminant hyper-inflammation or immunoparalysis is able to improve sepsis outcomes.
Primary Objectives:* To determine the efficacy of daily oral DP13 treatment (all dose arms combined) to decrease the plasma aldosterone-to-renin ratio (ARR) from baseline in patients with primary aldosteronism (PA)* To determine the efficacy of…
The overall objective of this trial will be to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-risk patients with isolated SSPE. Objective 1: To compare the frequency of symptomatic, recurrent venous…