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-…
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:-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…
Primary objective: to study the pharmacokinetics and pharmacodynamics of paracetamol intravenously in preterm infants with a gestational age of less than 32 weeks:Secondary objective(s): to study the safety and dose-effect relationship of…
Primary objective: - To study the pharmacokinetics of acetaminophen and metabolites in morbidly obese patients and compare with normal weight patients. Secondary objectives: - To compare the pharmacokinetics of acetaminophen and metabolites in…
The primary objective of this study is to assess whether *omics technologies are sensitive and specific enough to be used as a chemical risk assessment tool for humans. More specifically the study will demonstrate if there are different and / or…
To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice
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®
Primary research question:- Does treatment with drugs modulating vasoconstriction, i.e. COX-inhibitors (acetaminophen) or calcium-antagonists (nimodipine), improve electrographic postictal phenomena?Secondary research questions:- Does treatment with…
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 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 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…
Primary objective:To assess whether hydralazine in combination with valproate is effective in treating the symptoms of narcolepsy.Secondary objectives:- To assess the safety of treating NT1 patients with hydralazine in combination with valproate.-…
To assess the effect of a Roux-en-Y gastric bypass on the pharmacokinetics of a single oral dose of 1000 mg paracetamol before the surgery. within one month after the surgery and 6 months after the surgery.
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…