Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)
Summary
Several human genes affect how medications are metabolized by the body. It is believed that knowledge of variations of these genes can help health care providers better manage an anticoagulation medicine called warfarin (Coumadin®)and as a result decrease patient problems with bleeding or the development of blood clots. This study is designed to evaluate if genetic testing can improve warfarin initiation better than usual care.
Study Design
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Venous Thromboembolism
Intervention
Pharmacogenetic-based warfarin dosing, Usual care warfarin dosing
Location
University of Utah Health Care
Salt Lake City
Utah
United States
84132
Status
Completed
Source
University of Utah
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00634907
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Warfarin
An anticoagulant that acts by inhibiting the synthesis of vitamin K-dependent coagulation factors. Warfarin is indicated for the prophylaxis and/or treatment of venous thrombosis and its extension, pulmonary embolism, and atrial fibrillation with embolization. It is also used as an adjunct in the prophylaxis of systemic embolism after myocardial infarction. Warfarin is also used as a rodenticide.
Biomarkers, Pharmacological
Measurable biological parameters that serve for drug development, safety and dosing (DRUG MONITORING).
Acenocoumarol
A coumarin that is used as an anticoagulant. Its actions and uses are similar to those of WARFARIN. (From Martindale, The Extra Pharmacopoeia, 30th ed, p233)
Ethyl Biscoumacetate
A coumarin that is used as an anticoagulant. It has actions similar to those of WARFARIN. (From Martindale, The Extra Pharmacopoeia, 30th ed, p226)
Phenindione
An indandione that has been used as an anticoagulant. Phenindione has actions similar to WARFARIN, but it is now rarely employed because of its higher incidence of severe adverse effects. (From Martindale, The Extra Pharmacopoeia, 30th ed, p234)
Clinical Trials
Warfarin (also called Coumadin®) is an anticoagulant drug (blood thinner) given to patients to help prevent blood clots from forming or to help prevent the growth of an existing blood clo...
Warfarin is the most commonly used oral anticoagulant medicine (blood thinner). Although this medicine works well, it is difficult to know how much medicine a patient needs. Many things af...
Clarification of Optimal Anticoagulation Through Genetics
Individuals taking warfarin often need frequent dose changes as the INR gets too high or too low which could result in a higher risk of thromboembolism, bleeding and early discontinuation...
Clinical and Economic Implications of Genetic Testing for Warfarin Management
The purpose of this study is to explore how knowing genes that individuals inherit from their parents can make warfarin dosing more safe and effective. This study is being done to determi...
A Pharmacogenetic Study of Warfarin Dosing, "The COUMA-GEN Study"
Anticoagulation with warfarin is a common and potentially hazardous therapeutic intervention. It is a leading cause of iatrogenic bleeding events and, hence, of malpractice claims. There a...
PubMed Articles
ABSTRACT: BACKGROUND: Individuals with implanted mechanical valve prostheses require lifelong anticoagulation therapy with warfarin. The narrow therapeutic index of warfarin makes it difficult to dose...
PURPOSE: No consistent method is available for finding stable warfarin maintenance doses and fast stabilization of international normalized ratio (INR) values among healthy subjects in experimental wa...
Pharmacogenetic testing for warfarin dosing still awaits validation.
Proposal of pharmacogenetics-based warfarin dosing algorithm in Korean patients.
Warfarin is a commonly prescribed anticoagulant drug for the prevention of thromboembolic disorders. We investigated the contribution of genetic variations of four genes and clinical factors to warfar...
The Pharmacogenetics of the Response to Warfarin in Chinese.
Warfarin is a commonly used oral anticoagulant with a narrow therapeutic range and large inter-individual variability in daily dose. Compared with Caucasians, Chinese are known to require lower doses...