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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…

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…

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 (…

A Phase 3b, prospective, randomized, open-label, blind evaluator (PROBE) study evaluating the efficacy and safety of LMWheparin/edoxaban versus dalteparin in venous thromboembolism associated with cancer

The primary objective is to demonstrate the non-inferiority of edoxaban (preceded by a short course of LMWH compared with dalteparin for theprevention of the combined outcome of recurrent venous thromboembolism (VTE) or major bleeding in subjects…

Detecting and Diagnosing Atrial Fibrillation: enhanced case-finding in patients from general practice and evaluating three ways of irregular pulse detection. A cluster randomised trial with nested diagnostic studies

The study has two main objectives. The first objective is to estimate the extra yield in detected cases of AF in patients aged 65 years and over, using case finding. The second is to compare three methods to detect AF.

Dutch randomized trial comparing standard catheter-directed thrombolysis versus ultrasound-accelerated thrombolysis for thrombo-embolic infra-inguinal disease.

Te demonstrate that the use of US-accelerated catheter-derived thrombolysis in patients with recently (between 1 and 7 weeks) thrombosed infra-inguinal bypass grafts or native arteries will significantly reduce (at least 12 hours) therapy time…

Prospective study to the Optimal duration of Compression Therapy As prevention of chronic Venous Insufficiency After deep venous thrombosis

ACT reduces the incidence of PTS after DVT. In the Dutch CBO-guidelines current therapy is adviced for 2 years after diagnosis because most PTS develops within 2 years after DVT, with a peak incidence in the first year.Some clinicians claim that one…

*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…

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.…

Prospective, randomized, placebo-controlled, double-blind, multicenter, parallel-group, 24-week study to assess the efficacy, safety and tolerability of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension

Primary objective* To evaluate the effect of macitentan 10 mg on pulmonary vascular resistance (PVR) at rest in comparison with placebo in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH).Secondary objectives* To…

Medically Ill Patient Assessment of Rivaroxaban Versus Placebo IN Reducing Post-Discharge Venous Thrombo-Embolism Risk (MARINER)

Primary ObjectiveThe primary objective is to assess the efficacy and safety of rivaroxaban compared with placebo in the prevention of symptomatic venous thromboembolism (VTE) and VTE-related death posthospital discharge in high-risk, medically ill…

An international, multicenter, randomized, double-blind, placebocontrolled
phase 3 trial investigating the efficacy and safety of rivaroxaban
to reduce the risk of major thrombotic vascular events in patients with
symptomatic peripheral artery disease undergoing lower extremity
revascularization procedures

The primary efficacy objective of the study is:* to evaluate whether rivaroxaban added to ASA is superior to ASA alone in reducingthe risk of major thrombotic vascular events (defined as MI, ischemic stroke, CVdeath, ALI, and major amputation of a…

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…

Pilot-investigation: The reduction of embolic and there by neurologic complications after cardiac surgery by the use of a non-invasive imaging technique(CABG, on pump)

This pilot is meaned to obtain:- experience and understanding in the presence of new embolic load in the brain by means of DW-MRI- Understanding in the number of patients in which probably the post-operative DW-MRI can not be done according to…

Effect study ACRE

Zie pag. 8 protocol

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.…

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…