The Use of Aspirin to Reduce the Risk of Thrombotic Events in Patients With End-Stage Renal Disease: Protocol for a Randomized Controlled Trial.

Autor: Lemos Cerqueira T; Betim Nephrology Unit, Associaçao Evangélica Beneficente de Minas Gerais, Belo Horizonte, Brazil.; Harvard TH Chan School of Public Health, Harvard University, Boston, MA, United States.; Dresden International University, Dresden, Germany., Fartolino Guerrero A; Harvard TH Chan School of Public Health, Harvard University, Boston, MA, United States.; Family Health Strategy, São Paulo Municipal Health Department, São Paulo, Brazil., Pérez Fermin CK; Harvard TH Chan School of Public Health, Harvard University, Boston, MA, United States.; Hematology-Oncology Unit, Hospital Infantil Regional Universitario Dr Arturo Grullón, Santiago De Los Caballeros, Dominican Republic., Wang R; Harvard TH Chan School of Public Health, Harvard University, Boston, MA, United States.; Cardiology Department, Santa Casa de Belo Horizonte, Unimed Belo Horizonte, Belo Horizonte, Brazil., Balbino EE; Harvard TH Chan School of Public Health, Harvard University, Boston, MA, United States.; Agência Nacional de Vigilância Sanitária, Brasilia, Brazil., Breeze JL; Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, United States.; Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Tufts University, Boston, MA, United States., Gonzalez Mego P; Harvard TH Chan School of Public Health, Harvard University, Boston, MA, United States.; Suiza Laboratory, Lima, Peru., Argentina Silva D; Harvard TH Chan School of Public Health, Harvard University, Boston, MA, United States.; Faculdades Souza Marques, Rio de Janeiro, Brazil., Omer WE; Harvard TH Chan School of Public Health, Harvard University, Boston, MA, United States.; Hearing & Balance Unit, Hamad Medical Corporation, Doha, Qatar., Vandevelde NM; Harvard TH Chan School of Public Health, Harvard University, Boston, MA, United States.; Department of Quality of Medical Laboratories, Scientific Institute of Public Health, Brussels, Belgium.
Jazyk: angličtina
Zdroj: JMIR research protocols [JMIR Res Protoc] 2018 Aug 09; Vol. 7 (8), pp. e10516. Date of Electronic Publication: 2018 Aug 09.
DOI: 10.2196/10516
Abstrakt: Background: End-stage renal disease (ESRD) is the last stage of chronic kidney disease, mainly caused by type 2 diabetes mellitus and characterized by an increased mortality risk related to cardiovascular disease. Low-dose aspirin (acetylsalicylic acid or ASA) seems to effectively prevent cardiovascular events in patients with ESRD. However, the number of interventional studies in this population remains limited and the mechanisms of aspirin-related bleeding remain poorly understood. Aspirin's efficacy and safety may be modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity.
Objective: The overall objective of this protocol is to (1) evaluate aspirin's safety and efficacy in reducing the risk of thrombotic events in patients with ESRD on hemodialysis and (2) examine whether aspirin's efficacy is modified by the presence of type 2 diabetes mellitus or platelet hyperreactivity. Specifically, the primary objective is to compare the 12-month rate of any thrombotic event (cardiac death, nonfatal myocardial infarction, nonfatal stroke, arteriovenous fistula thrombosis) and Thrombolysis in Myocardial Infarction (TIMI) major bleeding in patients treated with aspirin compared to those on placebo. Secondary objectives are to test for effect modification of treatment by the presence of type 2 diabetes mellitus or platelet hyperreactivity and compare the rate of TIMI minor bleeding between treatment groups.
Methods: We developed a protocol for a phase 2 randomized, single-center, placebo-controlled, triple-blind, superiority clinical trial to assess the prophylactic efficacy and safety of aspirin in patients with ESRD and on hemodialysis. It follows the ethical principles of the Declaration of Helsinki of the World Medical Association. A total of 342 participants would be enrolled over 12 months at a large dialysis center. Patients will be randomized in a 1:1 ratio and stratified by presence of type 2 diabetes mellitus and platelet hyperreactivity to receive either oral aspirin (100 mg/d) or placebo for a treatment period of 12 months. An intention-to-treat statistical analysis will be performed.
Results: The randomized clinical trial will be performed after approval by the ethical committee of the participating center and registration at ClinicalTrials.gov.
Conclusions: We provide a protocol for a randomized controlled trial to evaluate the safety and efficacy of treatment with aspirin to reduce the risk of thrombotic events. In addition, such a study would further our understanding of the mechanism of aspirin-related bleeding and help identify subgroups of best-responders and patients with a higher risk of adverse events.
Registered Report Identifier: RR1-10.2196/10516.
(©Tiago Lemos Cerqueira, Armando Fartolino Guerrero, Clara Krystal Pérez Fermin, Ricardo Wang, Evelin Elfriede Balbino, Janis L Breeze, Paola Gonzalez Mego, Daniele Argentina Silva, Walid Ezzeldin Omer, Nathalie Monique Vandevelde. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 09.08.2018.)
Databáze: MEDLINE
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