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The effect of body weight on trough concentrations of DOACs in patients.

The aim of this study is to investigate the effect of body weight on the trough concentrations of DOACs. Eliquis®, Xarelto®, Lixiana® and Pradaxa®

Multicenter, open-label, active-controlled, randomized study to evaluate the efficacy and safety of an age-and body weight-adjusted rivaroxaban regimen compared to standard of care in children with acute venous thromboembolism

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…

A randomized controlled trial of rivaroxaban for the prevention of major cardiovascular
events in patients with coronary or peripheral artery disease (COMPASS - Cardiovascular
OutcoMes for People using Anticoagulation StrategieS)

Primary objectives:*To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces therisk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with…

Home Treatment of Patients with Low-Risk Pulmonary Embolism with the Oral Factor Xa Inhibitor Rivaroxaban: Prospective Management Trial (HoT-PE)

Objective of the study: Primary objective: to determine whether early discharge and out-of-hospital treatment of patients with low-risk acute PE (as defined by the inclusion and exclusion criteria) with the new oral factor Xa inhibitor rivaroxaban…

A multicentre, randomised, double-blind, controlled, phase IIIb study to assess the efficacy and safety of Rivaroxaban 10mg od versus Enoxaparin 4000 IU for VTE PROphylaxis in NOn Major Orthopaedic Surgery. The PRONOMOS study

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…

A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure

Despite continuous improvements in the medical management of pediatric patients with CHD, the risk of thrombotic events remains an important complication for pediatric patients following the Fontan procedure.The National Heart, Lung and Blood…

EvaluaTIoN of Clinical and laboratory outcomes of Rivaroxaban in short Bowel syndrome patients dEpending on Long term parenteral nutrition: a prospective cohort study (TINCRBEL study)

This study has been transitioned to CTIS with ID 2024-519078-38-00 check the CTIS register for the current data. 1) To evaluate the efficacy and safety of the standard clinical care at the AMC in this patient population by the clinical outcomes (…

Genotype-guided strategy for antithrombotic treatment versus conventional clopidogrel therapy in peripheral arterial disease.

This study has been transitioned to CTIS with ID 2024-518122-33-00 check the CTIS register for the current data. The primary aim of the GENPAD study is to evaluate the ability of genotype-guided antithrombotic treatment to reduce adverse clinical…

Trained immunity by dual-pathway inhibition (low-dose rivaroxaban and acetylsalicylic acid) in coronary artery disease

To demonstrate elevation in immune responsiveness to LPS stimulation when switching from ASA to DPI in patients with CAD, and to further explore whether changes in monocyte function and epigenetic landscape are responsible for the observed…

DUAL pathway inhibition (low-dose rivaroxaban and aspirin) as compared to aspirin only to improve endothelial function in peripheral artery disease (PAD)

To study the effectiveness of low-dose rivaroxaban with aspirin in improving endothelial function in patients with symptomatic or stable PAD.

An Open-Label Study to Assess the Effects of VMX-C001 in Combination with an Oral FXa DOAC on the Efficacy of Unfractionated Heparin in Healthy Subjects.

This study has been transitioned to CTIS with ID 2024-514339-87-00 check the CTIS register for the current data. Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.…

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacodynamics of Intravenously Administered Prothrombin Complex Concentrate (PCC) in Combination with a Selected FXa Direct Oral Anticoagulant (FXa DOAC) in Healthy Subjects.

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…

Clinical Surveillance vs. Anticoagulation for Low-risk Patients with Isolated Subsegmental Pulmonary Embolism: A Multicenter Randomized Placebo-Controlled Non-Inferiority Trial

This study has been transitioned to CTIS with ID 2023-506943-40-00 check the CTIS register for the current data. The overall objective of this trial will be to evaluate the efficacy and safety of clinical surveillance without anticoagulation in low-…

Switching anticoagulant management from a VKA to a NOAC-based tratment strategy in frail elderly patients with atrial fibrillation

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…

DOAC Levels prior to Incision study: DALI study

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.