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Nombre de programmes trouvés : 183
Conférences

le (12m26s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Post approval and registry studies (Roxana MEHRAN)

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012THE DEVICE THERAPY TRIALISTS WORKSHOPChairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USAWebcast: Tariq AHMAD, Durham, USADevice trial methodology, regulatory and implementation issuesAdvances in interventional medical devices are increasingly affecting cardiovascular therapy, just as pharmacological innovation did the generation before. Yet, designing and conducting a device trial is challenging and drug trial designs may not necessarily be applied fully to device trials.➢ Although there is increasing recognition that this development process substantially differs from that for drugs, how much device trial methodology may deviate from drug trial methodology ...
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Conférences

le (12m26s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : How to secure the optimal dose(s) for phase III? (Nancy GELLER)

MODIGLIANI Workshop 1 - Friday November 30, 2012 :THE THROMBOSIS TRIALISTS WORKSHOPDOSE AND TARGET PATIENT POPULATIONS ISSUESChairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN, Bucharest, ROMWebcast: Johanne SILVAIN, Paris, FRAThe development of new antithrombotic agents is a challenging area of cardiovascular medicine.These agents generally have a narrow therapeutic margin, and it is often difficult to find the optimal balance between efficacy (reduction of ischemic events) and safety (no excess of bleeding events).➢ Phase II trials are designed to generate signals of safety and efficacy and to select the dose or doses for phase III pivotal trials. However, phase II data ...
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Conférences

le (15m3s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 2 : Well Established Methods for Imaging Approaches, IVUS and IMT (Wolfgang KOENIG)

MODIGLIANI Workshop 2 - Friday November 30, 2012 :ATHEROSCLEROSIS IMAGING IN CLINICAL TRIALSFacilitating the discovery of effective therapiesChairpersons: Jagat NARULA, New York, USA - Ahmed TAWAKOL, Boston, USAWebcast: Bart STAELS, Lille, FRAPhase III clinical endpoint trials evaluating treatments for atherosclerosis typically require very large sample sizes, cost hundreds of millions of dollars and historically have had very low success rates. As a result, few new therapies that attenuate the progression of atherosclerosis have been identified in over 30 years (since the discovery of statins). Nearly a decade ago, in recognition of the low success of Phase III trials, regulatory agencies ...
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Label UNT Conférences

le (13m24s)

Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Target populations: How do we risk-stratify? Are additional biomarkers helpful?

Title : Cardiovascular Clinical Trialists (CVCT) Forum - Paris 2012 : Target populations: How do we risk-stratify? Are additional biomarkers helpful?Speaker: Wolfgang KOENIG, Ulm, GERDiscussant: Adrian HERNANDEZ, Durham, USAAbstract : LDL cholesterol (LDL-C) is causally involved in the atherosclerotic process and presents the major lipid variable for risk assessment, and statin therapy is guided by different levels of target LDL-C according to the absolute risk of the patient. Statins have revolutionized the treatment of hypercholesterolemia in patients without but also with manifest atherosclerosis and numerous trials since 4S have consistently documented a decrease in cardiovascular risk associated with decreases in LDL-C. Thus, ...
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