Long-Term Low-Molecular-Weight Heparin Versus Oral Anticoagulants in Deep Venous Thrombosis
Venous ThromboembolismThe purpose of this study is to evaluate whether low-molecular-weight heparin could be equally or more effective than oral anticoagulation in the long-term treatment of deep venous thrombosis.
Study of an Investigational Drug for the Prevention of Thrombosis-related Events Following Knee...
Deep Vein ThrombosisPulmonary EmbolismThe purpose of this study is to learn whether apixaban prevents the development of blood clots in the leg (deep vein thrombosis) and lung (pulmonary embolism), which sometimes occur after knee replacement surgery, and to compare the efficacy of apixaban with that of enoxaparin (Lovenox®) in the prevention of these clots. The safety of apixaban will also be studied.
Birth Control Pill vs Birth Control Patch Study
Venous ThrombosisThis study was a randomized, investigator-blinded, cross-over, clinic trial using twenty-four healthy women aged 18-35. All women received two months of the birth control patch or birth control pill, two months without any drug, then two months of the alternative drug. The birth control patch contained 0.75 milligrams ethinyl estradiol and 6 milligrams norelgestromin. The birth control pill contained 35 micrograms ethinyl estradiol and 250 micrograms norgestimate. Blood samples were taken before and after each treatment and were analyzed for the following lab values: D-dimer, von Willebrand factor, factor VIII, total and free protein S, antithrombin, fibrinogen, C-reactive protein and normalized activated protein C sensitivity ratio (nAPCsr). Two thrombin generation-based assays were used: the α2macroglobulin-thrombin endpoint method (α2M-IIa) and calibrated automated thrombinography (CAT).
SPIRIT III Clinical Trial of the XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
StentsCoronary Artery Disease6 moreThis study is divided into 5 arms: Randomized Clinical Trial (RCT): Prospective, randomized, active-controlled, single blind, parallel two-arm multi-center clinical trial in the United States (US) comparing XIENCE V® Everolimus Eluting Coronary Stent System (CSS) (2.5, 3.0, 3.5 mm diameter stents) to the Food and Drug Administration (FDA) approved commercially available active control TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent (TAXUS® EXPRESS2™ PECS) System US 2.25 mm non-randomized arm using 2.25 mm diameter XIENCE V® Everolimus Eluting CSS US 4.0 mm non-randomized arm using 4.0 mm diameter XIENCE V® Everolimus Eluting CSS US 38 mm non-randomized arm using 38 mm in length XIENCE V® Everolimus Eluting CSS Japanese non-randomized arm using XIENCE V® Everolimus Eluting CSS (2.5, 3.0, 3.5, 4.0 mm diameter stents) in Japan The TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System is Manufactured by Boston Scientific.
Prolongation of the Interval Between Monitoring of Warfarin in Stable Patients
Atrial FibrillationHeart Valve Diseases1 morePatients with mechanical heart valve prosthesis or with irregular beat (atrial fibrillation) have a high risk of blood clot formation. Such clots can result in a stroke. The patients are treated with warfarin - a "blood thinner" - to prevent these complications. The treatment has to be monitored with a blood test called Prothrombin time (PT) every 1-4 weeks. The dose of warfarin has to be changed whenever the PT result is outside of the treatment range. If the result is too low there is an increased risk of blood clots. If, instead, the result is too high there is a risk of bleeding. One third of the patients have very stable PT results and hardly ever have to change the dose. The investigators hypothesis is that these patients can go less often, e.g. every 12 weeks, for the blood tests.
A Pharmacogenetic Study of Warfarin Dosing, "The COUMA-GEN Study"
Atrial FibrillationDeep Vein Thrombosis1 moreAnticoagulation 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 are no good alternatives presently for warfarin anticoagulation, and even when alternatives become available (i.e., ximelagatran), cost, labeling, and experience (outcomes-related) issues will continue to favor an extensive and ongoing use of warfarin. If the present study is able to confirm an advantage for a genotype-driven algorithm, in terms of improved efficiency, therapeutic efficacy, and, especially, safety, then a pharmacogenetics approach to warfarin dosing can be recommended as the basis for an Intermountain Health Care (IHC)-wide quality improvement initiative that should improve patient outcomes, reduce resource use (costs of achieving safe and therapeutic anticoagulation), and reduce adverse clinical events. COUMA-GEN is a prospective, randomized study of patients who are to begin chronic warfarin therapy for specific, qualifying clinical reasons (i.e., atrial fibrillation (AF), deep vein thrombosis (DVT), or post-orthopedic surgery prophylaxis). Qualifying patients will be consented and randomized to an individualized, genotype-based warfarin-dosing regimen or to standard care (without knowledge of genotype). In each study arm, a predicted maintenance dose will be determined. All patients will receive a baseline International Normalized Ratio (INR). For patients in all 3 entry strata, a starting dose of warfarin that is twice the assigned daily maintenance dose (according to the specific treatment arm) will be prescribed on the first and second days, and then the dose will revert to the assigned maintenance dose.
Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis...
Deep Vein ThrombosisPatients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.
Study Of Angiomax In Infants Under Six Months With Thrombosis
ThrombosisThe goals of this study are: To assess the safety of bivalirudin in infants under six months with arterial or venous thrombosis; To determine the dose of bivalirudin required to achieve adequate anticoagulation as measured by the activated clotting time (ACT) or activated partial thromboplastin time (aPTT) in Infants Under Six Months with arterial or venous thrombosis; To determine the outcome of patients on bivalirudin with respect to thrombus resolution and bleeding complications compared to patients on unfractionated heparin (UH) or low molecular weight heparin (LMWH).
Dietary Effects on Lipoproteins and Thrombogenic Activity (DELTA)
Cardiovascular DiseasesCoronary Disease5 moreTo evaluate the effects of carefully controlled diets on lipoproteins and clotting factors in different demographic groups.
NASH Fitness Intervention in Thrombosis Trial (NASHFit)
Liver DiseasesBlood Disorder1 moreNonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in the United States. The most advanced forms of NAFLD are associated with increased liver-related mortality and lower overall survival. The current standard of care for NAFLD is lifestyle changes through diet and exercise. The human genome and regulation of gene expression is influenced by physical activity. NAFLD is a prothrombotic state with derangements in all three phases of hemostasis leading to clinically important clotting events. Exercise can improve coagulation in healthy persons. In this proposal, we seek to begin a line of work to answer the question "Can lifestyle changes effectively mitigate the increased risk of clotting in patients with NAFLD?" focusing initially on the at-risk population genetically susceptible to advanced disease.