Background: Early and complete restoration of target vessel patency in ST-elevation myocardial infarction (STEMI) is associated with improved outcomes. Oral P2Y inhibitors have failed to demonstrate either improved patency or reduced mortality when administered in the prehospital setting. Thus, there is a need for antiplatelet agents that achieve prompt and potent platelet inhibition, and that restore patency in the prehospital setting. Zalunfiban, a novel subcutaneously administered glycoprotein IIb/IIIa inhibitor designed for prehospital administration, has shown to achieve rapid, high-grade platelet inhibition that exceeds that of P2Y inhibitors. Whether prehospital administration of zalunfiban can improve clinical outcome is unknown.
Hypothesis: The present study is designed to assess the hypothesis that a single, prehospital injection of zalunfiban given in the ambulance, in addition to standard-of-care in patients with STEMI with intent to undergo primary percutaneous coronary intervention (PCI) will improve clinical outcome compared to standard-of-care with placebo.
Study Design: The ongoing CELEBRATE trial (NCT04825743) is a phase 3, randomized, double-blinded, placebo-controlled, international trial. Patients with STEMI intended to undergo primary PCI will receive treatment with a single subcutaneous injection containing either zalunfiban dose 1 (0.110 mg/kg), zalunfiban dose 2 (0.130 mg/kg) or placebo, and the study drug will be administered in the ambulance before transportation to the hospital. A target of 2499 patients will be randomly assigned to one of the treatment groups in a 1:1:1 ratio, ie, to have approximately 833 evaluable patients per group. The primary efficacy outcome is a ranked 7-point scale on clinical outcomes. The primary safety outcome is severe or life-threatening bleeding according to the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) criteria.
Summary: The CELEBRATE trial will assess whether a single prehospital subcutaneous injection of zalunfiban in addition to standard-of-care in patients with STEMI with intent to undergo primary PCI will result in improved clinical outcome.
Download full-text PDF |
Source |
---|---|
http://dx.doi.org/10.1016/j.ahj.2022.12.015 | DOI Listing |
Leukemia
December 2024
Faculty of Medicine and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, University of Cologne, Cologne, Germany.
Indolent mature B-cell neoplasms are a group of diseases in which recent therapeutic advances have led to an improved overall survival (OS) extending beyond several years. While cause of celebration for patients and caregivers, the increasingly long observation periods necessary to capture treatment effects are complicating trial design and possibly hindering swift access to more effective therapies. Surrogate endpoints are a tool with the potential of earlier study readouts, however, their validity needs to be proven in each individual disease and therapeutic setting.
View Article and Find Full Text PDFProc Natl Acad Sci U S A
November 2024
Toulouse School of Economics, Toulouse 31080, France.
We provide experimental evidence that role models can galvanize prosocial actions amid global crises, exemplified by the COVID-19 pandemic. In a randomized control trial comparing role models, cash incentives, and celebrity endorsements, only role models successfully mitigated vaccine reluctance and ameliorated pandemic-induced educational setbacks. Monthly tracking of vaccination status was achieved via QR-code-verified certificates.
View Article and Find Full Text PDFFront Nutr
October 2024
Center of Excellence in Preventive and Integrative Medicine and Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Background: Thai desserts, celebrated for their exquisite sweetness, are widely enjoyed for personal indulgence and as cherished souvenirs. However, their high sugar content raises concerns regarding health impacts. This study aimed to quantify the glycemic index (GI) and glycemic load (GL) in healthy volunteers following consumption of various Thai desserts, out of 10 renowned desserts from across Thailand, identified by the Tourism Authority of Thailand, characterized by differing sugar levels.
View Article and Find Full Text PDFCureus
September 2024
Biostatistics, The Oxford Center, Brighton, USA.
The randomized controlled trial (RCT) is widely esteemed as the gold standard of experimental research methodologies, purportedly due to its rigorous approach to achieving statistical control. By systematically assigning participants to either a control group or an experimental group through randomization, RCTs claim to isolate the effects of the intervention from confounding variables. This methodological rigor is believed to be instrumental in ensuring that observed outcomes can be attributed with a high degree of confidence to the experimental treatment rather than to extraneous factors.
View Article and Find Full Text PDFNPJ Parkinsons Dis
October 2024
Department of Electrical and Computer Engineering, The Johns Hopkins University, Baltimore, MD, USA.
Numerous studies proposed methods to detect Parkinson's disease (PD) via speech analysis. However, existing corpora often lack prodromal recordings, have small sample sizes, and lack longitudinal data. Speech samples from celebrities who publicly disclosed their PD diagnosis provide longitudinal data, allowing the creation of a new corpus, ParkCeleb.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!