Search results for "endpoint"
showing 7 items of 437 documents
Open-label ODYSSEY APPRISE study: Interim data from the first 843 participants
2018
Background PCSK9 inhibitors (PCSK9i) have been recommended by the ESC/EAS Task Force in very high risk subjects with ASCVD and those with heterozygous familial hypercholesterolemia (HeFH) with persistent high LDL-C levels despite maximally tolerated LLT. Purpose ODYSSEY APPRISE (NCT02476006) is the first study to assess efficacy and safety at Week (W) 12 of the PCSK9i alirocumab (ALI) in a real-life setting prior to commercial availability. Methods APPRISE was an open-label, single-arm study, conducted in 16 European countries and Canada. Subjects with inadequately controlled lipid levels despite maximally tolerated LLT were included. Based on physician's judgment, participants received eit…
Impact of Platelet Reactivity in ACS Patients on Clinical Outcomes with Triple Antithrombotic Therapy
2021
Optimal antithrombotic therapy after percutaneous coronary intervention (PCI) in patients on oral anticoagulants (OAC) remains a clinical conundrum. In fact, combining an OAC with dual antiplatelet therapy (triple antithrombotic therapy, TAT) increases the risk of bleeding. Clopidogrel is the only thienopyridine recommended in TAT patients. Whether its response plays a relevant role in this setting remains uncertain. We aimed to evaluate the level of platelet reactivity inhibition (PRI) achieved by oral TAT in Acute Coronary Syndrome (ACS) patients undergoing PCI and its relationship with outcomes. We performed a multicenter prospective observational study and assessed PRI by vasodilator-st…
Pressure support ventilation + sigh in acute hypoxemic respiratory failure patients: Study protocol for a pilot randomized controlled trial, the PROT…
2018
Background Adding cyclic short sustained inflations (sigh) to assisted ventilation yields optimizes lung recruitment, decreases heterogeneity and reduces inspiratory effort in patients with acute hypoxemic respiratory failure (AHRF). These findings suggest that adding sigh to pressure support ventilation (PSV) might decrease the risk of lung injury, shorten weaning and improve clinical outcomes. Thus, we conceived a pilot trial to test the feasibility of adding sigh to PSV (the PROTECTION study). Methods PROTECTION is an international randomized controlled trial that will be conducted in 23 intensive care units (ICUs). Patients with AHRF who have been intubated from 24 h to 7 days and under…
Mid-term and late results of endovascular treatment for symptomatic carotid artery stenosis under proximal protection
2021
Introduction: Although filters are still preferred during carotid stenting, proximal protection systems (PPS) are increasingly used during these procedures. PPS seem to be safer than distal systems, especially in symptomatic patients, but evidence supporting their use is limited. Aim: This was a post hoc survey with 30-day mid-term and long-term follow up, which was aimed at assessment of the safety and efficacy of stenting of the internal carotid artery under PPS in symptomatic patients. Material and methods: We analysed the results of stenting in 120 symptomatic patients presenting with at least 60% stenosis. Patients were aged 67.9 ±9.8 years, and 12 patients were older than 80 years. An…
A methodological look at the controversy about the influence of salt intake on cardiovascular risk
2012
Cardiovascular diseases are a major cause of premature death and disability. They represent an extraordinarily strong financial burden upon health-care systems in ‘‘developed’’ countries. Elevated blood pressure is a major cause of cardiovascular disease. There is much evidence that cardiovascular risk increases from normal blood pressure (i.e., from 115/75 mmHg upwards) [1]. Overwhelming evidence shows that reducing salt intake from 9–12 g/day to 5–6 g/day lowers blood pressure [2]. Blood pressure is a surrogate endpoint, but may be related to a reduction of morbidity and mortality due to cardiovascular causes. Thus, intensive support and encouragement to cut down on the intake of salt in …
Real-world experience with obeticholic acid in patients with primary biliary cholangitis
2021
Background & aims Obeticholic acid (OCA) is the second-line treatment approved for patients with primary biliary cholangitis (PBC) and an inadequate response or intolerance to ursodeoxycholic acid. We aimed to evaluate the effectiveness and safety of OCA under real-world conditions. Methods Patients were recruited into the Italian PBC Registry, a multicentre, observational cohort study that monitors patients with PBC at national level. The primary endpoint was the biochemical response according to Poise criteria; the secondary endpoint was the biochemical response according to normal range criteria, defined as normal levels of bilirubin, alkaline phosphatase (ALP), and alanine aminotransfer…