23 results
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
To evaluate the feasibility, safety and efficacy related endpoints for the Fractyl Revita System for the treatment of uncontrolled type 2 diabetes.
To compare the performance and diagnostic accuracy of two EUS-guided tissue acquisition devices; a 25G Echotip Ultra Fine Needle Aspiration (FNA) device and a new, more flexible, 20G Echotip ProCore Fine Needle Biopsy (FNB) device.
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
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…
To evaluate the safety (bleeding) of 4 doses of apixaban as compared to placebo over a 26 week treatment period in selected subjects with recent (<=7 days) Acute Coronary Syndrome (ACS). To determine the optimal dose and regimen of apixaban…
To demonstrate that oral apixaban 2.5 mg BID is superior to subcutaneous (SC)enoxaparin 40 mg QD in reducing the event rate on the composite endpoint of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death through Day 12 of…
The main objective of this pilot study is to evaluate the efficacy of the Duodenal Mucosal Resurfacing procedure combined with GLP-1 administration and lifestyle intervention in subjects with insulindependent type 2 diabetes. Study success is…
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…
Phase 1 (0 - 24 Weeks) Objective:To study the effect of DMR on glycemic and mechanistic endpoints24 weeks post-procedure in subjects with T2D.Phase 2 (24 - 48 Weeks) Objective:To study the effect of DMR on glycemic endpoints for assessment…
To evaluate that the oral FXIa inhibitor BAY 2433334 when compared to apixaban leads to a lower incidence of bleeding in participants with AF
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…
The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®
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.
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…
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 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…
- 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 determine if the use of apixaban in patients with SCAF will reduce the incidence of stroke and systemic embolism compared to aspirin.