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A prospective Randomised, open label, blinded endpoint (PROBE) study to Evaluate DUAL antithrombotic therapy with dabigatran etexilate (110mg and 150mg b.i.d.) plus clopidogrel or ticagrelor vs. triple therapy strategy with warfarin (INR 2.0 - 3.0) plus clopidogrel or ticagrelor and aspirin in patients with non valvular atrial fibrillation (NVAF) that have undergone a percutaneous coronary intervention (PCI) with stenting

See section 2.2 of the protocol.The main objective of this study is to compare a DAT regimen of 110mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (110mg DE-DAT) and 150mg dabigatran etexilate b.i.d. plus clopidogrel or ticagrelor (…

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…

Dutch randomized trial comparing Ultrasound-accElerated Thrombolysis with standard dose Urokinase versus half dose Urokinase for thrombo-embolic infra-inguinal arterial disease (DUET II)

To demonstrate that the use of US-accelerated catheter-derived thrombolysis in patients with recently (less than 7 weeks) thrombosed infra-inguinal bypass grafts or native arteries with half the dose urokinase (50.000 IU/h) will significantly reduce…

Long-term treatment for cancer patients with deep vein thrombosis or pulmonary embolism - a randomized open label study

The primary efficacy objective is to evaluate whether LMWH is superior to VKAs in the long-term treatment of symptomatic VTE in cancer patients who completed 6 to 12 months of anticoagulant treatment. Two aspects are important: the efficacy with…

Vitamin K1 to slow vascular calcification in hemodialysis patients (VitaVasK)

The aim of the study is to show that a therapy based on a thrice weekly administration (i.e. at each HD session) of vitamin K1 for a period of 18 months attenuates the progression of coronary artery and thoracic aortic calcifications compared to…

Multi Center Clinical trial of endovascular treatment of acute ischemic stroke in the Netherlands.

The primary objective of this study is to estimate the effect of endovascular treatment on overall functional outcome after acute ischemic stroke of less than six hour duration, in patients with a symptomatic anterior circulation IAO. The secondary…

INTERVENTIONAL MANAGEMENT OF STROKE TRIAL CLINICAL PROTOCOL - IMS III
A phase III, randomized, multi-center, open label, 900 subject clinical trial that will examine whether a combined intravenous (IV) and intra-arterial (IA) approach to recanalization is superior to standard IV rt-PA (Activase®/Actilyse®) alone when initiated within three hours of acute ischemic stroke onset.

The primary objective of the trial is to determine if ischemic stroke subjects with a baseline NIH Stroke Scale Score (NIHSSS] >= 10 (8-9 with positive CTA) treated with recombinant tissue plasminogen activator (rt-PA; [Alteplase recombinant…

Single dose open-label PK/PD, safety and tolerability of dabigatran etexilate mesilate given at the end of standard anticoagulant therapy in successive groups of children aged 2 years to less than 12 years and 1 year to less than 2 years.

To provide single dose PK/PD dataTo investigate tolerability and safety of dabigatran etexilate solution in children1 to <12 years of age

Pilot Study for assessing Diagnostic Techniques for Central Venous Catheter-related Venous Thromboembolism

Primary Objectives:To (1) Assess the feasibility and tolerability of performing US and/or contrast-enhanced MRI in children with central venous catheters (CVCs) or peripherally inserted central catheters (PICC lines); (2) assess the accuracy of US…

Thrombolysis Or Anticoagulation for Cerebral venous Thrombosis

The objective of this study is to determine the clinical efficacy of endovascular thrombolytic treatment (ET) as compared to standard treatment (any therapeutic heparin regimen) in patients with proven cerebral venous sinus thrombosis and a high…

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…

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…

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…

Effect study ACRE

Zie pag. 8 protocol

Oral direct factor Xa inhibitor rivaroxaban in patients with acute symptomatic deep-vein thrombosis or pulmonary embolism using a strong CYP 3A4 inducer.

The purpose of this study is to demonstrate that in patients with DVT or PE who use a strong CYP 3A4 inducer, the use of this higher rivaroxaban dose results in a similar rivaroxaban concentration in the blood and a rivaroxaban induced blood…

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…

Antiplatelet therapy in combination with Recombinant t-PA Thrombolysis in Ischemic Stroke

The objective of this trial is to investigate whether adding acute APT to rt-PA thrombolysis in ischemic stroke reduces death or dependency at 3 months.

The Impact of Intraoperative Carbon Dioxide Wound Ventilation on Cerebral Microembolic Load during Aortic Arch Surgery : a Prospective Randomized Clinical Trial using Transcranial Doppler Ultrasound

The primary objective of this study is to evaluate the impact of carbon dioxide field flooding on the quantitative intraoperative microembolic load of the brain during aortic arch surgery.A secondary objective is to evaluate any concomitant…

AN OPEN-LABEL CLINICAL TRIAL OF INTRA-ARTERIAL MICROPLASMIN ADMINISTRATION IN PATIENTS WITH ACUTE INTRACRANIAL VERTEBROBASILAR ARTERY OCCLUSION

To evaluate the safety and the arterial recanalization potential of microplasmin when administered intra-arterially in patients with acute intracranial vertebrobasilar artery occlusion.

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…