Xarelto Regulatory Post-Marketing Surveillance
Summary
This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA).
1. Known and unknown adverse reactions, especially serious adverse reactions
2. Incidence of adverse reactions under the routine drug use
3. Factors that may affect the safety of the drug
4. Factors that may affect the effectiveness of the drug
5. Other safety information related to overuse, drug interaction and laboratory abnormalities
6. Other adverse reactions
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Conditions
Venous Thromboembolism
Intervention
Rivaroxaban (Xarelto, BAY59-7939), Pharmacologic agents (e.g. LMWH/VKA/Fondaparinux/Aspirin and etc.)
Location
Many Locations
Korea, Republic of
Status
Recruiting
Source
Bayer
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01029743
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Bone Marrow Purging
Techniques for the removal of subpopulations of cells (usually residual tumor cells) from the bone marrow ex vivo before it is infused. The purging is achieved by a variety of agents including pharmacologic agents, biophysical agents (laser photoirradiation or radioisotopes) and immunologic agents. Bone marrow purging is used in both autologous and allogeneic BONE MARROW TRANSPLANTATION.
Oral Sprays
Pharmacologic agents in the form of a mist or spray delivered into the body through the mouth.
Chemistry, Pharmaceutical
Chemistry dealing with the composition and preparation of agents having PHARMACOLOGIC ACTIONS or diagnostic use.
Belladonna Alkaloids
Alkaloids obtained from various plants, especially the deadly nightshade (Atropa belladonna), variety acuminata; atropine, hyoscyamine and scopolamine are classical, specific antimuscarinic agents with many pharmacologic actions; used mainly as antispasmodics.
Pharmacologic Actions
A broad category of chemical actions and uses that result in the prevention, treatment, cure or diagnosis of disease. Included here are drugs and chemicals that act by altering normal body functions, such as the REPRODUCTIVE CONTROL AGENTS and ANESTHETICS. Effects of chemicals on the environment are also included.
Clinical Trials
The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to f...
BAY59-7939 in Atrial Fibrillation Once Daily (OD)
This is an exploratory investigation of safety, pharmacokinetic (PK) and pharmacodynamic (PD) effects of BAY59-7939 with multiple oral doses of 10 mg, 15 mg and 20 mg once daily (od) in Ja...
BAY59-7939 Japanese in Atrial Fibrillation (2nd)
This study was a randomized, parallel group, open label trial using warfarin as comparator. Pharmacokinetics (PK) and pharmacodynamics (PD) were investigated only in BAY59-7939 groups (ori...
Patients undergoing surgery, especially hip and knee surgery, are at high risk for VTE. The administration of drugs for thromboprophylaxis, such as heparins, significantly lowers that risk...
The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It directly inhibits factor Xa, a blood component in the pathway which leads to coagulation (clot...
PubMed Articles
PURPOSE OF REVIEW: Several randomized controlled trials have shown that pharmacological thromboprophylaxis with low-dose unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparin...
The discovery and development of rivaroxaban, an oral, direct factor Xa inhibitor.
The activated serine protease factor Xa is a promising target for new anticoagulants. After studies on naturally occurring factor Xa inhibitors indicated that such agents could be effective and safe,...
Rivaroxaban in the prevention and treatment of thromboembolic disorders.
Rivaroxaban (Xarelto®) is a new anticoagulant for the prevention and treatment of thromboembolic disorders. Rivaroxaban inhibits coagulation factor Xa directly, has high oral bioavailability, shows l...
Aims: The objective of this study was to evaluate the cost-effectiveness of rivaroxaban versus the low-molecular-weight heparins (LMWH) enoxaparin and dalteparin for the prevention of venous thromboem...
Long-term benefits of preventing venous thromboembolic events.
Abstract Background: Venous thromboembolism (VTE) and its long-term secondary complications are major health problems associated with high rates of morbidity and mortality and considerable costs for h...
