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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…

Anti-Xa activity after a reduced therapeutic dose of nadroparin in patients with renal impairment using a dosage guideline of the Dutch Federation of Nephrology

The primary objective of this study is to determine the anti-Xa activity after a reduced therapeutic dose of nadroparin in patients with an eGFR < 60 ml/min in comparison with the anti-Xa activity after a standard therapeutic dose of…

The Need for Titration or Monitoring of Direct Oral Anticoagulant Treatment: The MONDOAC and KIDOAC study

To determine the within and between variability of pharmacokinetic (PK) profiles in patients treated with DOACs in daily practice

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…

Portal implementation within anticoagulation care; amplification of selfmanagement.

The main aim is to investigate clinical effects of different implementation methods of online supported self-management for thrombosis patients in primary care. Secondary objectives include well-being, health care use and actual use of the portal.…

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.

Prospective registry of management and outcome of bleeding complications in patients treated with non-vitamin K antagonist oral anticoagulants (NOACs)

Primary objectiveTo assess the outcome of NOAC associated bleeds and emergency invasive surgery or procedures. Secondary objectives1) To describe the treatment of patients presenting with NOAC associated bleeding2) To evaluate the current…

A randomized, double-blind, placebo-controlled, 4-period, two part cross-over study to evaluate the potential interaction effect between 4 mg/kg and 16 mg/kg sugammadex and enoxaparin or unfractionated heparin on anticoagulation activity in young healthy male volunteers

To investigate the potential of an interaction between 4 mg/kg and 16 mg/kg sugammadex and enoxaparin or UFH on anticoagulant activity in young healthy male volunteers.

Multiple-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and
Tolerability of Apixaban in Paediatric Subjects with an Indwelling Central Venous
Catheter

There is no formal primary research hypothesis to be statistically tested. The purpose of this study is to evaluate the pharmacokinetics, the pharmacodynamics, the safety profile and tolerability following multiple oral doses of apixaban in…

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…

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

Long term, multicenter, single-arm, open-label extension study of the MERIT-1 study, to assess the safety, tolerability and efficacy of macitentan in subjects with inoperable chronic thromboembolic pulmonary hypertension (CTEPH)

Safety objective:• To evaluate the long-term safety and tolerability of macitentan 10 mg in subjects withinoperable CTEPH.Efficacy objectives:• To evaluate the long term effects of macitentan 10 mg on exercise capacity andfunctional class (FC).

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…

The Efficacy of Pro- and Anticoagulant Therapy in Plasma of Patients with Cirrhosis undergoing Orthotopic Liver Transplantation

To investigate the in vitro effect of both pro- and anticoagulation therapy on thrombin generation by Calibrated Automated Thrombography in plasma from patients with cirrhosis undergoing liver transplantation.

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…

WATCHMAN Implantation during Hybrid Atrial Fibrillation Ablation

The primary objective of this study is to investigate the safety and feasibility of implanting a WATCHMAN Device in a hybrid setup for AF ablation.

Long-term outcome after heparin plus edoxaban versus heparin plus vitamin K antagonists for acute deep vein thrombosis and pulmonary embolism

To assess the long-term PE-related Quality of Life and to assess the cumulative incidence of PTS in patients with acute DVT, treated with heparin plus edoxaban in comparison to patients treated with heparin plus warfarin. Furthermore, the…

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…