42 results
- Assess the incidence of major bleeding and clinically relevant non-major bleeding- Assess the incidence of recurrent venous thromboembolism- Assess the asymptomatic deterioration in the thrombotic burden on repeat imaging- Characterize the…
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…
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…
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…
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…
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…
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 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…
1. To compare the following imaging technologies to the current practice of histology of pelvic lymph node dissection: a. PSMAGa68 PET b. Nano MR Lymphography and an enhanced arterial map (Nano MRL / EAM) to locate the position of the lymph nodes2.…
To validate the use of 3 and 7 Tesla nano-MRI in restaging locally advanced rectal cancer by node-to-node matching of the results of nano-MRI with pathology as the gold standard.
To study the effectiveness of low-dose rivaroxaban with aspirin in improving endothelial function in patients with symptomatic or stable PAD.
1) To evaluate the efficacy and safety of the standard clinical care at the AMC in this patient population by the clinical outcomes (recurrent) thrombotic events and bleeding complications respectively.2) To evaluate the change in quality of life in…
The first objective is to improve preoperative staging with 3T NANO-MRI regarding the detection of lymph node metastases in patients with a pancreatic or periampullary carcinoma when compared to a conventional contrast-enhanced CT or MRI. Other…
The objective of this trial is to compare standard treatment with radium-223-chloride (proven surivval benefit) with treatment with rhenium-188-HEDP, which is nowadays only used for pain palliation. This trial includes patients with metastatic…
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…
The primary aim of the GENPAD study is to evaluate the ability of genotype-guided antithrombotic treatment to reduce adverse clinical events related to arterial thrombosis in patients with peripheral arterial disease. Secondary aims are to evaluate…
Primary Objectives1. To confirm superiority of Ferrotran®-enhanced MRI over unenhanced MRI in sensitivity to detect metastases in normal size pelvic lymph nodes in using histopathology after lymph node dissection as established reference method (…
Primary:• To assess the effects of VMX-C001 and a DOAC on the anticoagulant effect of unfractionated heparin in healthy subjects.Secundary:• To assess the safety and tolerability of VMX-C001 in a simulated emergency use setting.• To assess the…
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 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…