Ensayos clínicos

This is a Phase 1b, double-blind (Principal Investigators, study subjects, Sponsor, Academic Research Organization ARO and Clinical Research Organization CRO blinded), placebo-controlled, randomized, single-ascending dose, multi-center study to assess the safety, efficacy, tolerability, pharmacokinetics PK, and pharmacodynamics PD of DS-1040b in subjects with acute submassive pulmonary embolism.

The goal of this project is to determine if the change in oxygen saturation during deep inspiration ("augmented pulse oximetry") can be used as a method to rule out pulmonary embolism (PE). The investigators propose to evaluate a simple, non-invasive clinical tool to help rule out PE. The investigators plan to measure the oxygen saturation of 40 consecutive patients with newly-diagnosed PE (within 60 minutes of diagnosis) and 80 matched controls who do not have a PE. Trained, blinded Respiratory Therapists will record each patient's oxygen saturation before, during, and after a 2-minute period of deep inspirations (vital capacity [the ...

PEPPER is a randomized study comparing the three most commonly used anticoagulants in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The anticoagulants being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

The purpose of this study is to evaluate the effectiveness and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism events and related death after hospital discharge in high-risk, medically ill patients.

The purpose of this registry will be to promote a greater understanding of the prevalence, pathophysiology, evaluation, and treatment of United States patients with chronic thromboembolic pulmonary hypertension through shared information, education, and collaborative investigation among pulmonary hypertension centers throughout the U.S.

PRESERVE is a multi-center, prospective, open-label, non-randomized investigation of commercially available IVC filters from 7 manufacturers placed in subjects for the prevention of pulmonary embolism (PE). This study will enroll approximately 2,100 IVC filter subjects at up to 60 sites in the US. All treated subjects will be evaluated at procedure, 3-months, 6-months (phone), 12-months, 18-months (phone), and 24-months post-procedure. The primary objective of this investigational device exemption (IDE) clinical investigation is to evaluate the safety and effectiveness of the commercially available IVC filters (retrievable and permanent) in subjects with clinical need for mechanical prophylaxis of PE with an IVC ...

PEPPER is a randomized study comparing the three most commonly used anticoagulants in North America in patients who have elected to undergo primary or revision hip or knee joint replacement surgery. The anticoagulants being compared are enteric coated aspirin, low intensity warfarin, and rivaroxaban.

The primary objective of this multicenter, prospective, single arm clinical trial is to evaluate the safety and effectiveness of the Angel® Catheter in subjects at high risk of PE, and with recognized contraindications to standard pharmacological therapy (anticoagulation).

The purpose of this study is to evaluate the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) events and VTE-related death post-hospital discharge in high-risk, medically ill patients.

The Researchers are studying whether a vascular boot warming program plus standard of care anticoagulation can be a safe and effective method to resolve Deep Vein Thrombosis (DVT) ±Pulmonary Embolism (PE) earlier and prevent development of post-thrombotic syndrome (PTS). Additionally, to learn whether a more detailed imaging of the affected lower extremities will provide a more accurate and reliable method to guide treatment for this condition.

This randomized phase III trial studies the best dose of apixaban and how well it works in preventing secondary cancer related blood clots in cancer patients who have completed anticoagulation therapy. Apixaban may stop the clotting of blood by blocking some of the enzymes needed for blood clotting.

The purpose is to create a registry of patients at Mayo Clinic who are prescribed the new novel anticoagulation therapy with either rivaroxaban, dabigatran, apixaban, oe edoxaban to allow post marketing survelliance with particular attention to cancer patients treated with novel anticoalants which in marketing studies the patient numbers were small. We also want to compare efficacy and safety of novel anticoagulants to "traditional" anticoagulants such as warfarin and low molecular weight heparin (LMWH) and therefore to register patients treated with this type of anticoagulation to our registry too.

The purpose of this study is to create and maintain a clinical database of patients with history of, or who are at high risk for thromboembolic diseases, along with a plasma/serum repository. We plan to evaluate novel biomarkers that might be associated with thromboembolic diseases and test whether these biomarkers will help predict the incident and recurrentrecurrences of thromboembolic episodes and other outcomes (e.g., mortality, post thrombotic syndrome).

The purpose of this study is to compare the effect of a blood thinning drug called Apixaban versus no administration of a blood thinning drug, in preventing blood clots in children with leukemia or lymphoma. Patients must be receiving chemotherapy, including asparaginase, and have a central line (a catheter inserted for administration of medications and blood sampling).