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Prophylaxis of venous thromboembolism in patients with a fracture of the lower extremity being treated conservatively with a below-knee plaster cast.

The purpose of this study is to determine the need for thromboprofylaxis in patients being treated in a below-knee plaster cast after trauma of a lower extremity and if there is, to assess if both of the two tested prophylactic treatments are suited…

Reduced-dosed rivaroxaban and standard-dosed rivaroxaban versus ASA in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis and/or pulmonary embolism
The Einstein Choice Study

1. The primary efficacy objective is to evaluate whether rivaroxaban, in doses of 10 mg or 20 mg, is superior to ASA 100 mg in the prevention of the primary efficacy outcome (i.e. fatal or non-fatal symptomatic recurrent venous thromboembolism).2.…

*Cost-effectiveness of tailoring anticoagulant therapy by a VTE recurrence prediction model in patients with venous thrombo-embolism as compared to care-as-usual: the VISTA study.*

OBJECTIVESThe objective is to quantify the cost-effectiveness and efficacy of formally applying the guideline evaluating the risk-benefit ratio of the duration of anticoagulant therapy (VKA treatment) by a previously developed VTE recurrence…

Anticoagulant treatment after knee arthroscopy or during plaster cast lower leg immobilisation: determining the balance between benefits and risks

Comparative effectiveness research to determine cost-effectiveness of an existing healthcare policy, i.e. treatment with low molecular weight heparin (LMWH) after knee arthroscopy and lower leg plaster cast immobilization following surgical or…

Risk factor profiling for future arterial cardiovascular events in patients wih unprovoked pulmonary embolism

Currently, no established risk factor profile for developing arterial cardiovascular events after an acute unprovoked PE exists and is carried out in general practice. The aim of our project is to prospectively study the relation between presence…

A Phase 3 Randomized, Double-blind, Parallel-group, Multi-center Study of the Safety
and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill
Medical Subjects During and Following Hospitalization

To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended…

Individually tailored elastic compression therapy after deep venous thrombosis in relation to the incidence of post thrombotic syndrome, a randomized multicenter trial

To assess the costs and effects of tailoring the duration of elastic compression stocking (ECS) therapy after deep vein thrombosis (DVT) to individual patients needs.

Plasma anti Xa-levels in obese patients undergoing bariatric surgery and receiving low molecular weight heparins for thromboprophylaxis.

The purpose of the proposed study is to investigate the anti-Xa levels of enoxaparin in patients after bariatric surgery and to correlate these with actual body weight.

Once-daily oral direct factor Xa rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism. The Einstein-Extension study.

The purpose of this study is to show that the incidence of new thrombotic events during an additional 6 or 12 months of treatment with rivaroxaban is lower when compared to placebo and that the likely advantage of an extended effect is not offset by…

A phase 3, randomized, double-blind, active controlled (enoxaparin 40 mg QD), parallel-group, multi-center study to evaluate the safety and efficacy of Apixban in subjects ondergoing elective total knee replacement surgery.

To demonstrate that oral apixaban 2.5 mg BID is superior to subcutaneous (SC)enoxaparin 40 mg QD in reducing the event rate on the composite endpoint of adjudicated asymptomatic and symptomatic DVT, non-fatal PE and all-cause death through Day 12 of…

EUropean Pharmacogenetics of AntiCoagulant Therapy trial

To determine whether a dosing algorithm containing genetic information increases the time within therapeutic INR range during anticoagulation therapy with phenprocoumon compared to a dosing regimen that does not contain this genetic information.…

EUropean Pharmacogenetics of AntiCoagulation Therapy trial

To determine whether a dosing algorithm containing genetic information increases the time within therapeutic INR range during anticoagulation therapy with acenocoumarol compared to a dosing regimen that does not contain this genetic information.…

Dalteparin Sodium Injection (FRAGMIN®), Multicenter, Open Label, Single-Arm, Long Term (52 weeks) Study for Understanding Safety and Efficacy in Subjects with Malignancies and symptomatic Venous Thromboembolism

The primary objective of the study is to determine the rate of majorbleeding events in cancer subjects receiving extended treatment withdalteparin (> 6 months and up to 12 months) for prevention ofrecurrent symptomatic venous thromboembolism…

Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism.

For the Einstein-DVT evaluation. The primary efficacy objective is to evaluate whether rivaroxaban is at least as effective as enoxaparin/VKA in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) without symptomatic…

MAGELLaN - Multicenter, rAndomized, parallel Group Efficacy and safety study for the prevention of venous thromboembolism in hospitalized medically iLL patients comparing rivaroxabAN with enoxaparin

The objective of this study is to demonstrate (1) the superior efficacy of VTE prophylaxis with oral rivaroxaban 10 mg once daily administered for 35 ± 4 days to SC enoxaparin 40 mg once daily (OD) administered for 10 ± 4 days in men and women aged…

TropicALL study; Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with
Low-molecular-weight heparin: a randomized controlled trial

Main objective:To assess the efficacy of thromboprophylaxis with high prophylactic dose LMWH as compared with standard care without systemic thromboprophylaxis in children treated for primary ALL during asparaginase treatment.Secondary objectives:1…

What is the optimal antithrombotic strategy in patients presenting with acute coronary syndrome having atrial fibrillation with indication for anticoagulants?

1. To investigate the efficacy of dual therapy (omitting acetylsalicylic acid) compared to triple therapy in patients with atrial fibrillation and acute coronary syndrome.2. To investigate the safety of dual therapy (omitting acetylsalicylic acid)…

Apixaban versus antiplatelet drugs or no antithrombotic drugs after anticoagulation-associated intracerebral haemorrhage in patients with atrial fibrillation. A randomised phase II clinical trial.

Primary Objective: to obtain reliable estimates of the rates of vascular death and non-fatal stroke in patients with atrial fibrillation and a recent anticoagulation-associated ICH who are treated with apixaban versus those who are treated with APDs…

Prospective study into the relation between bodyweight en the effect of thrombosis prophylaxis in patients admitted to hospital

The objective of the study is to evaluate in a prospective setting the effect of body weight on anti-Xa levels in the blood after administration of prophylactic nadroparin 2850 IE to patients admitted to the hospital. Second, we want to see what the…

SafePass: A prospective, non-randomized, multi-center, open-label,
clinical investigation to assess the safety and technical performance of the Emboliner
embolic protection catheter.

The primary objectives are to evaluate preliminary data on the safety and performance of theEmboliner embolic protection catheter.Safety:Assess procedural safety risksPerformance:Assess the technical performance in conjunction with a TAVR procedure.