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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…

Cost-effectiveness of a lifestyle intervention on health and sustainable employability among workers of 40 years and older with high physical work demands: a randomized controlled trial

- to evaluate (cost-) effectiveness of a personalized health intervention among workers of 40 years and older with high physical work demands to contribute to a reduction in CVD and sustainable employability.

IMPella versus IABP REduces mortality in STEMI patients treated with primary PCI IN SEVERE and deep cardiogenic SHOCK.
An international multicenter, randomized trial of the Impella cVAD (left ventricular assist) device versus Intra Aortic Balloon Counter Pulsation (IABP) therapy for acute ST-elevation myocardial infarction patients treated with primary PCI in severe and deep cardiogenic shock

The primary objective of this study is to determine whether the Impella cVAD device vs. IABP therapy leads to a higher 30 day survival rate in shock STEMI patients in the setting of primary PCI.

Protocol I1V-MC-EIAN Assessment of Clinical Effects of Cholesteryl Ester Transfer Protein Inhibition with Evacetrapib in Patients at a High-Risk for Vascular Outcomes - the ACCELERATE Study

The primary objective of this study is to test the hypothesis that evacetrapib 130 mg daily, in comparison to placebo, reduces the incidence of the composite endpoint of cardiovascular (CV) death, myocardial infarction (MI), stroke, coronary…

IOinated contrast DILution in digital subtraction angiography of the limb:
a randomized controlled trial with three different concentrations of iodine

To compare the confidence of the interventional radiologist in diagnosing and treating arterial stenoses and occlusions by digital subtraction angiography with contrast concentrations of 300, 240 and 140 mg iodine per ml. Also, we will compare the…

TELEHYPE TELEmonitoring and self-management of uncontrolled HYPErtension

To assess the one-year (cost)effectiveness of telemonitoring of blood pressure and self-management support via an internet-based service in addition to usual care as compared to usual care alone in a pragmatic trial in patients with uncontrolled…

A SINGLE ORAL ASCENDING DOSE STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF RO6836191 IN HEALTHY MALE VOLUNTEERS INCLUDING A SINGLE INTRAVENOUS DOSE OF RO6836191

The study will be performed in 2 parts, Parts 1 and Part 2. The purpose of this study is to investigate to what extent RO6836191 is tolerated. It will also be investigated how quickly and to what extent RO6836191 is absorbed and eliminated from the…

Clinical effectiveness of standard versus pathogen-reduced buffy coat-derived platelet concentrates in plasma in hemato-oncological patients;Pathogen Reduction Evaluation & Predictive Analytical Rating Score (The PREPAReS Study)

A prospective randomized phase III clinical trial to study the effectiveness of pathogen-reduced platelet concentrates in plasma, stored for up to 7 days, and compare these with untrested platelet concentrates in plasma, stored for up to 7 days. The…

A placebo-controlled, double-blind, randomized trial to compare the effect of treatment on plaque burden as determined by intravascular ultrasound and to evaluate the efficacy, pharmacokinetics, safety, and tolerability of MDCO-216 given as multiple weekly infusions in subjects with a recent acute coronary syndrome.

Primary ObjectivesTo evaluate the effect of MDCO-216 treatment on the change in PAV of a target coronary artery as measured by IVUS imaging following five weekly infusions of MDCO-216 (20 mg/kg) compared with placebo in subjects with a recent ACS.…

TElmisartan in the management of abDominal aortic aneurYsm
(TEDY)

The aim of this study is to investigate if telmisartan reduces AAA growth

A Double-blind, Randomised, Placebo-controlled, Phase 2b/3 Adaptive Clinical Trial Investigating the Efficacy and Safety of Selepressin as Treatment for Patients with Vasopressor-dependent Septic Shock

To demonstrate superiority of selepressin plus standard care versus placebo plus standard care in the number of vasopressor- and mechanical ventilator-free days (with penalty for mortality) in patients with vasopressor-dependent septic shock

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 placebo-controlled, double-blind, randomized trial to compare the effect of different doses of ALN-PCSSC given as single or multiple subcutaneous injections in subjects with high cardiovascular risk and elevated LDL-C.

PRIMARY OBJECTIVE The primary objective of this study is to evaluate the effect of ALN-PCSSC treatment on LDL-C levels at Day 180. SECONDARY OBJECTIVESThe secondary objectives of this study are to evaluate the effect of ALN-PCSSC on the following…

Pilot study added value intermittent vacuum therapy (IVT)

To determine the effect of IVT on walking distance after 6 and 12 weeks, 6 months and 1 year in patients with IC who are treated with a SET program. To determine the optimal timing for IVT within the SET program.

A Phase 1b, Randomized, Double-Blind (Sponsor Open), Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of PF-04447943, Co-Administered with and Without Hydroxyurea, in Subjects with Stable Sickle Cell Disease

Primary ObjectiveTo determine the safety and tolerability of multipledoses of PF-04447943 Secondary ObjectiveTo characterize the PK of PF-04447943 in plasma following oral administrationExploratory ObjectivesTo evaluate biomarkers that may be…

BIOFLOW-V: BIOTRONIK * A Prospective Randomized Multicenter Study to Assess the SaFety and Effectiveness of the Orsiro SiroLimus Eluting Coronary Stent System in the Treatment Of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions * V

To assess the safety and efficacy of the Orsiro Sirolimus Eluting Coronary Stent System in the treatment of subjects with up to three native de novo or restenotic (standard PTCA only) coronary artery lesions compared to the Xience coronary stent…

Comparison of BIOdegradable Polymer and DuRablE Polymer Drug-eluting Stents in an
All COmeRs PopulaTion (BIO-RESORT): Randomized Multicenter Trial in an All Comers Population Treated Within thE NeThErlands 3 (TWENTE 3)

The aim of the study is to compare the outcome of two DES with biodegradable polymer coatings separately (Orsiro and Synergy) versus an established third-generation durable polymer DES with proven efficacy and safety (Resolute Integrity) in an all…

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 (…

Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ])

1. The primary objective is to assess the effects of four 250 mg PC-mAB (also referred to as "3G10") once monthly intravenous injections on monocyte function ex vivo. The secondary objectives are to:1. assess the functional effects of 3G10…