RT Journal Article
T1 The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy and safety of an active strategy for the diagnosis and treatment of acute pulmonary embolism during exacerbations of chronic obstructive pulmonary disease.
A1 Jimenez, David
A1 Agusti Alvar, 
A1 Monreal, Manuel
A1 Otero, Remedios
A1 Huisman, Menno V
A1 Lobo, Jose L
A1 Quezada, Andres
A1 Jara-Palomares, Luis
A1 Hernando, Ascension
A1 Tabernero, Eva
A1 Marcos, Pedro
A1 Ruiz-Artacho, Pedro
A1 Ballaz, Aitor
A1 Bertoletti, Laurent
A1 Couturaud, Francis
A1 Yusen, Roger
K1 chronic obstructive pulmonary disease
K1 exacerbation
K1 pulmonary embolism
K1 treatment
AB Some previous studies have suggested a high prevalence of pulmonary embolism (PE) during exacerbations of chronic obstructive pulmonary disease (ECOPD). The SLICE trial aims to assess the efficacy and safety of an active strategy for the diagnosis and treatment of PE (vs usual care) in patients hospitalized because of ECOPD. SLICE is a phase III, prospective, international, multicenter, randomized, open-label, and parallel-group trial. A total of 746 patients hospitalized because of ECOPD will be randomized in a 1:1 fashion to receive either an active strategy for the diagnosis and anticoagulant treatment of PE or usual care (ie, standard care without any diagnostic test for diagnosing PE). The primary outcome is a composite of all-cause death, non-fatal (recurrent) venous thromboembolism (VTE), or readmission for ECOPD within 90 days after enrollment. Secondary outcomes are (a) death from any cause within 90 days after enrollment, (b) non-fatal (recurrent) VTE within 90 days after enrollment, (c) readmission within 90 days after enrollment, and (d) length of hospital stay. Enrollment started in September 2014 and is expected to proceed until 2020. Median age of the first 443 patients was 71 years (interquartile range, 64-78), and 26% were female. This multicenter trial will determine the value of detecting PEs in patients with ECOPD. This has implications for COPD patient morbidity and mortality. NCT02238639.
PB John Wiley & Sons, Inc.
YR 2019
FD 2019-03-12
LK http://hdl.handle.net/10668/13492
UL http://hdl.handle.net/10668/13492
LA en
NO Jiménez D, Agustí A, Monreal M, Otero R, Huisman MV, Lobo JL, et al. The rationale, design, and methods of a randomized, controlled trial to evaluate the efficacy and safety of an active strategy for the diagnosis and treatment of acute pulmonary embolism during exacerbations of chronic obstructive pulmonary disease. Clin Cardiol. 2019 Mar;42(3):346-351.
NO The study is supported by public funding, specifically by a grant from the Spanish Government (Ministry of Health; PI14/00400). In addition, the Sponsor has obtained grants from the Chest Foundation Research Grant in Venous Thromboembolism, Sociedad Española de Neumología y Cirugía Torácica (SEPAR) and from Daiichi-Sankyo. According to the study protocol, neither the Spanish Government, Chest, SEPAR nor any part of the industry is involved at any stage of design, conduct of the trial, data management and data analysis or may exert any influence on decisions to discontinue the trial due to futility or safety concerns.
DS RISalud
RD Aug 23, 2025