17 results
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-…
Primary:-To assess the impact of educational programme on implementation phase adherence in patients taking apixaban for Stroke Prevention in Non-Valvular Atrial Fibrillation (SPAF) at 24 weeks.Secondary:-To identify predictive risk factors linked…
A phase Ib / II randomized study of BI 836845 in combination with exemestane and everolimus versus exemestane and everolimus alone in women with locally advanced or metastatic breast cancer.With following objectives:Phase Ib part: To determine the…
Primary objective: to confirm the efficacy of insulin degludec administered once daily plus mealtime insulin aspart in controlling glycaemia with respect to change from baseline in HbA1c after 26 weeks of treatment. Secundary objective: to compare…
To demonstrate that anticoagulation with the direct factor Xa inhibitor apixaban is not less safe than VKA therapy in patients undergoing catheter ablation of non-valvular AF in the prevention of peri-procedural complications. The substudy involving…
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
Primary Objective: to obtain reliable estimates of the rates of vascular death and non-fatal stroke in patients with atrial fibrillation and a recent anticoagulation-associated ICH who are treated with apixaban versus those who are treated with APDs…
The primary objective of this study is to evaluate the proportion of patients achieving FXI inhibition * 80% at trough (Day 91) after monthly dosing at 3 dose levels of MAA868.
To evaluate that the oral FXIa inhibitor BAY 2433334 when compared to apixaban leads to a lower incidence of bleeding in participants with AF
The primary objective of this study is to assess whether abelacimab is non-inferior to apixaban for preventing VTE recurrence at 6 months postrandomization in patients with cancer and recently diagnosed VTE. If noninferiority is demonstrated, then…
To determine if the use of apixaban in patients with SCAF will reduce the incidence of stroke and systemic embolism compared to aspirin.
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…
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…
- To demonstrate that asundexian is superior (at least non-inferior) when compared with apixaban for prevention of stroke and systemic embolism in participants with atrial fibrillation at risk for stroke- To demonstrate that asundexian is superior…
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.
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…