The Treatment of Acute Pulmonary Thromboembolism (PE) of GSK576428 (Fondaparinux Sodium) in Japanese...
EmbolismPulmonaryThe primary objective is to evaluate the efficacy (as measured by the rate of recurrent symptomatic Venous Thromboembolism [VTE] (i.e., Pulmonary thromboembolism [PE] and Deep Vein Thrombosis [DVT])) and safety of GSK576428 as the initial treatment in subjects with acute PE in an open-label design.
Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism (VTE) in Medical Patients With...
Medical PatientsRenal InsufficiencyFondaparinux is a parenteral anticoagulant drug and is approved for the prevention of venous thromboembolism in high risk medical patients. A relevant proportion of medical patients have moderate to severe renal insufficiency, which is an independent risk factor for bleeding. This risk may be further increased when low molecular weight heparin or fondaparinux are administered in patients with severe renal insufficiency, defined by a creatinine clearance of lower than 30 mL/min. No clear indications are available to reduce such risk in patients who require thromboprophylaxis. A lower dose of fondaparinux, 1.5 mg daily, has been recently approved for the prevention of venous thromboembolism in the specific population of patients with a creatinine clearance between 20 and 50 mL/min (European Marketing Authorization). However, there are to our knowledge no clinical studies that have assessed the safety and efficacy of this reduced dosage in medical patients.
Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein...
Venous ThromboembolismThe purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.
Prospective, Multi-center, Single-arm Study to Assess the Safety of Retrieval of the Recovery G2...
Pulmonary EmbolismVenous Thromboembolic DiseaseThis study was designed to assess the safety of retrieval of the Bard Recovery® G2® Filter System. The G2 filter is an FDA-cleared device for inferior vena caval interruption in patients with pulmonary thromboembolism.
Prospective Genotyping For Total Hip or Knee Replacement Patients Receiving Warfarin (Coumadin)...
Venous ThromboembolismBleedingSeveral 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 was designed to evaluate if genetic testing can improve warfarin initiation better than usual care.
Safety and Tolerability of Dabigatran Etexilate in Adolescents
Venous ThromboembolismTo investigate the safety and tolerability of dabigatran etexilate capsules in a small group of eight adolescent patients.
Michelangelo - Oasis 5
ThromboembolismStudy Objectives PRIMARY OBJECTIVE: To evaluate whether fondaparinux is at least as effective as or superior to enoxaparin in preventing death, myocardial infarction or refactory ischemia up to Day 9 in the acute treatment of patients with unstable angina/non ST-segment elevation myocardial infarction concurrently managed with standard medical therapy. SECONDARY OBJECTIVE: If non inferiority of fondaparinux is established on initial statistical analysis in a second step, superiority of fondaparinux to enoxaparin will be evaluated statistically. To determine whether fondaparinux is superior to enoxaparin in reducing death or MI at Day 9 To determine whether fondaparinux is superior to enoxaparin in reducing major bleeding events up to Day 9 To determine whether the relative effect on the primary end point of fondaparinux versus enoxaparin is sustained at Day 14, Day 30, Day 90 and Day 180 Study Drug: Patients will be randomized to receive either: Fondaparinux 2.5 mg once and placebo-enoxaparin twice daily by subcutaneous injection or Enoxaparin (1mg/kg) twice and fondaparinux-placebo once daily by subcutaneous injection Duration of Therapy: Fondaparinux 2.5mg daily for 8 days or hospital discharge (whichever is earlier) Enoxaparin 1mg/kg b.i.d. x 2-8 days or until clinically stable. Patients should receive an ASA and all other standard medical therapies. Substudy: A substudy comparing routine early coronary angiography immediately or as soon as possible (but no later than 24 hours after randomization) and intervention versus delayed (>48 hrs) coronary angiography and intervention. Primary Outcome: The first occurence of any component of the following composite up to Day 9: Death Myocardial Infarction Refractory Ischemia
Assessment of Long-Term Out-of-Hospital Treatment of Patients With Proximal Deep Vein Thrombosis...
ThrombosisThromboembolism1 moreThe purpose of this study is to assess the long-term out-of-hospital treatment of patients with proximal venous thrombosis through the administration of subcutaneous low-molecular-weight heparin (tinzaparin sodium) versus low-molecular-weight heparin followed by warfarin sodium.
Impact of Remote Care in Patients Diagnosed With Thromboembolic Disease of Low Risk
Thromboembolic DiseaseThe goal of this clinical trial is to learn about the feasibility and impact of remote care in patients diagnosed with thromboembolic disease of low risk. The main questions it aims to answer are: the evaluation of feasibility of organisation between different healthcare professionals (hospital physicians, primary care physician) at 6 months and 1 year the evaluation of complication rate, hospitalisation related to thromboembolic disease rate, compliance to treatment rate at 6 months and 1 year Participants will receive indication of treatment according to national recommendations. Additionnally, they will receive for the length of study a 4G tablet in order to fill questionnaires, learn information about their drugs (patient education), have a remote consultation and evaluate treatment compliance.
Rivaroxaban Plus Aspirin to Manage Recurrent Venous Thromboembolic Events
Venous ThromboembolismAnticoagulant-induced Bleeding2 moreVenous thromboembolism affects around 10 million people per year worldwide, however, despite its high incidence, there is no systematic review or randomized trial focused on the treatment of patients with recurrent deep vein thrombosis (DVT) and/or or pulmonary embolism (PE) during anticoagulant treatment. The objective was to compare the use of Rivaroxaban plus Aspirin versus Acenocoumarol in patients with recurrent venous thromboembolism treated with rivaroxaban.