Safety, Pharmacokinetics, and Pharmacodynamics of ARC1779 in Healthy Volunteers
ThrombosisThe purpose of this study is to establish the overall safety and tolerability of ARC1779 in healthy volunteers, and to characterize its pharmacokinetic and pharmacodynamic profile with respect to parameters of platelet function and von Willebrand Factor activity.
Pilot Dose Finding and Pharmacokinetic Study of Fondaparinux in Children With Thrombosis
ThrombosisHeparin-induced ThrombocytopeniaThis study will evaluate the use of a blood thinner, fondaparinux, which is approved for use in adults (not in children) in a children aged 1-18 years. Subject with a blood clot (thrombosis) or heparin-induced thrombocytopenia who need to be on a blood thinner will be eligible to participate. Subjects will receive a once daily dose of fondaparinux followed by blood tests at 2, 4, 12, and 24 hours after the first dose in order to determine the proper dose for this age group. The hypothesis is that children receiving fondaparinux will be able to receive a once daily dose. The currently available alternative agent, enoxaparin, needs to be given twice daily. In addition, an evaluation of the safety of this medication will be made by assessing for side effects, especially bleeding.
Effects of Micronized Fenofibrate on Fasting and Postprandial Lipoproteins, Inflammatory Mediators...
Hypertriglyceridemia With the Metabolic SyndromeThis is a randomized placebo controlled clinical trial designed to investigate the effects of micronized fenofibrate on fasting and postprandial lipoproteins, oxidized fatty acids and lipoproteins, inflammatory mediators and thrombotic factors among hypertriglyceridemic individuals with two or more other characteristics of the metabolic syndrome.
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.
Clarification of Optimal Anticoagulation Through Genetics
StrokeVenous Thrombosis2 moreIndividuals taking warfarin often need frequent dose changes as the international normalized ratio (INR) gets too high or too low which could result in a higher risk of thromboembolism, bleeding and early discontinuation of a highly useful therapy. This study will compare two approaches to warfarin dosing to examine the utility of using genetic information for warfarin dosing.
Clinical Study Assessing Idrabiotaparinux Sodium Injections Once-weekly in Pulmonary Embolism Therapeutic...
EmbolismThrombosisObjectives are to evaluate whether idrabiotaparinux sodium (SSR126517E) is as least as effective as a standard warfarin treatment to prevent recurrence of venous thromboembolic events (VTE) in patients with symptomatic pulmonary embolism (PE) with or without symptomatic deep venous thrombosis (DVT) and to assess its safety (bleedings) versus warfarin.
Evaluation of Long-Term Sequelae After Thrombophlebitis, i.e. Deep Venous Thrombosis of the Lower...
Deep Venous ThrombosisThe purpose of the study was to evaluate efficacy and safety of the new acute treatment of deep venous thrombosis by use of low-molecular-weight heparin compared with standard treatment using unfractionated heparin, especially concerning long-term morbidity.
Absence of Residual Vein Thrombosis Permits to Withdrawn Oral Anticoagulants
Deep Vein ThrombosisBackground. The optimal duration of oral anticoagulant treatment in patients with idiopathic Deep Vein Thrombosis (DVT)of the lower limbs is still uncertain. Residual Vein Thrombosis (RVT) has been found able to establish the patient' risk for recurrent thrombotic events. In the present study we conducted a RVT-based therapeutic strategy, withholding OAT after 3 months in patients without RVT while continuing anticoagulants for at least additional 9 months in those in whom RVT persists. Methods Patients with a first episode of symptomatic unprovoked proximal Vein Thrombosis (VT) were given Oral Anticoagulant Treatment (OAT) for 3 months. Residual Vein Thrombosis (RVT), ultrasonographically-detected, will be then assessed. Patients without RVT did not continue OAT (Group B), whereas those with RVT will continue OAT for at least additional 9 months. Patients were followed-up prospectively focusing on the study outcomes: occurrence of recurrent venous thromboembolism and major bleeding over a period of at least 12 months after OAT discontinuation.
Low-Dose Alteplase to Treat Blood Clots in Deep Leg Veins
Acute Deep Venous Thrombosis of the Lower ExtremityThis study will test the effectiveness of low-dose recombinant tissue plasminogen activator (rtPA, or alteplase) in dissolving blood clots in deep leg veins. Alteplase is used to clear blood clots in coronary arteries in patients having heart attacks. Blood clots can develop in the deep leg veins causing pain and swelling and may break loose and lodge in the lungs. Current routine treatments use anticoagulants such as heparin stop the clots from enlarging and prevent clots from moving to the lung but do not reliably dissolve clots in the leg.In an earlier study we showed that rtPA could be used to actually dissolve the clots. This study will determine whether lower doses of rtPA can dissolve clots with fewer bleeding complications than the current higher-dose regimens. Patients 18 years of age and older who have blood clots in a deep vein of the pelvis or leg may be eligible for this study if they have had symptoms for 14 days or less and if they have never had clots in their deep veins before. Participants are admitted to hospital for up to 5 days. On the first treatment day, the patient has a venogram to show the location of the clots. The radiologist injects an x-ray contrast material into a small vein in the foot and watches the dye by x-ray as it moves up the leg, revealing the clot(s). A catheter (plastic tube) is then inserted into a vein either behind the knee, in the groin, or in the neck, and advanced until it reaches the clots. When the catheter is in place, rtPA is injected while the radiologist watches the vein under the x-ray image. The amount of rtPa needed will depends on the size of the clot. Up to five venograms may be done if the clot requires the maximum four rtPA treatments allowed in this study. During the treatments, patients receive standard doses of heparin, given continuously by vein, After completion of treatments, anticoagulation is continued through use of a low molecular weight heparin (usually enoxaparin) given by subcutaneous injection as a transition medication during conversion to anticoagulation with warfarin ( also known as coumadin), another blood thinner, taken by mouth. Patients continue taking warfarin for 6 months. During thrombolytic therapy, blood samples are drawn shortly before the first dose of rtPA and at five time points afterward to measure the rtPA in the circulation and other factors that indicate whether the rtPA is affecting clotting ability. Blood also is drawn at least once a day to monitor heparin levels. To evaluate the impact of treatment on the function of the leg, patients return to the Rehabilitation Medicine Department and Radiology department at about 6 weeks (4 to 8 week ) and 6 months for clinical and imaging evaluation of impact of therapy on venous function. The objectives are to determine how well this treatment will restore venous function and whether this can be done safely- without causing bleeding complications, which have been the main risks of previous thrombolytic treatments.
Treatment of Upper Extremity Deep-Vein Thrombosis
Deep-Vein ThrombosisThe purpose of this study is to document the long-term outcome or prognosis of patients diagnosed with upper extremity deep-vein thrombosis who are treated with Fragmin (dalteparin sodium injection) for three months.