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Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism

How to prevent recurrences after a first venous thromboembolic (VTE) event in elderly patients is still an open issue, especially because of the high bleeding risk of anticoagulation in these patients. The placebo-controlled “Jason” study aims at assessing the efficacy and safety for secondary VTE p...

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Autores principales: Palareti, Gualtiero, Legnani, Cristina, Antonucci, Emilia, Zorzi, Serena, Bignamini, Angelo A., Lodigiani, Corrado, Tosetto, Alberto, Bertù, Lorenza, Pengo, Vittorio, Testa, Sophie, Ageno, Walter, Prisco, Domenico, Prandoni, Paolo, Poli, Daniela
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7952285/
https://www.ncbi.nlm.nih.gov/pubmed/32451933
http://dx.doi.org/10.1007/s11739-020-02381-5
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author Palareti, Gualtiero
Legnani, Cristina
Antonucci, Emilia
Zorzi, Serena
Bignamini, Angelo A.
Lodigiani, Corrado
Tosetto, Alberto
Bertù, Lorenza
Pengo, Vittorio
Testa, Sophie
Ageno, Walter
Prisco, Domenico
Prandoni, Paolo
Poli, Daniela
author_facet Palareti, Gualtiero
Legnani, Cristina
Antonucci, Emilia
Zorzi, Serena
Bignamini, Angelo A.
Lodigiani, Corrado
Tosetto, Alberto
Bertù, Lorenza
Pengo, Vittorio
Testa, Sophie
Ageno, Walter
Prisco, Domenico
Prandoni, Paolo
Poli, Daniela
author_sort Palareti, Gualtiero
collection PubMed
description How to prevent recurrences after a first venous thromboembolic (VTE) event in elderly patients is still an open issue, especially because of the high bleeding risk of anticoagulation in these patients. The placebo-controlled “Jason” study aims at assessing the efficacy and safety for secondary VTE prevention in elderly patients of oral Sulodexide (Vessel(®)) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy) which proved effective against recurrences in a general population (SURVET study) without major bleeding (MB) complications. 1450 patients, aged ≥ 75 years, after at least 3 months of anticoagulation treatment for a first VTE episode, are double-blind randomized to receive for 12 months either sulodexide 500 lipasemic units (LSUs) twice daily, or sulodexide 250 LSU twice daily + indistinguishable placebo, or indistinguishable placebo. Primary outcomes for efficacy are the composite of death for VTE and recurrent VTE, and occurrence of MB for safety. Secondary outcomes include stroke, cardiovascular death and other thromboembolic events, and MB + clinically relevant non-MB. The first patient is scheduled to be randomized in May 2020. The study protocol has been approved by AIFA (Agenzia Italiana del Farmaco) and the Ethics Committee of the coordinating center. Written informed consent will be obtained from all patients prior to study participation. Jason study is an investigator-initiated trial, promoted by “Arianna Anticoagulazione” Foundation, Bologna, Italy, and supported by Alfasigma, Bologna, Italy. Study findings will be disseminated to participant centers, at research conferences and in peer-reviewed journals. Trial registration numbers NCT 04257487; EudraCT (2019–000570-33). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11739-020-02381-5) contains supplementary material, which is available to authorized users.
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spelling pubmed-79522852021-03-28 Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism Palareti, Gualtiero Legnani, Cristina Antonucci, Emilia Zorzi, Serena Bignamini, Angelo A. Lodigiani, Corrado Tosetto, Alberto Bertù, Lorenza Pengo, Vittorio Testa, Sophie Ageno, Walter Prisco, Domenico Prandoni, Paolo Poli, Daniela Intern Emerg Med Im - Original How to prevent recurrences after a first venous thromboembolic (VTE) event in elderly patients is still an open issue, especially because of the high bleeding risk of anticoagulation in these patients. The placebo-controlled “Jason” study aims at assessing the efficacy and safety for secondary VTE prevention in elderly patients of oral Sulodexide (Vessel(®)) administration, a mixture of glycosaminoglycans (Alfasigma, Bologna, Italy) which proved effective against recurrences in a general population (SURVET study) without major bleeding (MB) complications. 1450 patients, aged ≥ 75 years, after at least 3 months of anticoagulation treatment for a first VTE episode, are double-blind randomized to receive for 12 months either sulodexide 500 lipasemic units (LSUs) twice daily, or sulodexide 250 LSU twice daily + indistinguishable placebo, or indistinguishable placebo. Primary outcomes for efficacy are the composite of death for VTE and recurrent VTE, and occurrence of MB for safety. Secondary outcomes include stroke, cardiovascular death and other thromboembolic events, and MB + clinically relevant non-MB. The first patient is scheduled to be randomized in May 2020. The study protocol has been approved by AIFA (Agenzia Italiana del Farmaco) and the Ethics Committee of the coordinating center. Written informed consent will be obtained from all patients prior to study participation. Jason study is an investigator-initiated trial, promoted by “Arianna Anticoagulazione” Foundation, Bologna, Italy, and supported by Alfasigma, Bologna, Italy. Study findings will be disseminated to participant centers, at research conferences and in peer-reviewed journals. Trial registration numbers NCT 04257487; EudraCT (2019–000570-33). ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s11739-020-02381-5) contains supplementary material, which is available to authorized users. Springer International Publishing 2020-05-25 2021 /pmc/articles/PMC7952285/ /pubmed/32451933 http://dx.doi.org/10.1007/s11739-020-02381-5 Text en © The Author(s) 2020 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
spellingShingle Im - Original
Palareti, Gualtiero
Legnani, Cristina
Antonucci, Emilia
Zorzi, Serena
Bignamini, Angelo A.
Lodigiani, Corrado
Tosetto, Alberto
Bertù, Lorenza
Pengo, Vittorio
Testa, Sophie
Ageno, Walter
Prisco, Domenico
Prandoni, Paolo
Poli, Daniela
Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism
title Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism
title_full Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism
title_fullStr Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism
title_full_unstemmed Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism
title_short Design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism
title_sort design and rationale of a randomized, placebo-controlled trial on the efficacy and safety of sulodexide for extended treatment in elderly patients after a first venous thromboembolism
topic Im - Original
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7952285/
https://www.ncbi.nlm.nih.gov/pubmed/32451933
http://dx.doi.org/10.1007/s11739-020-02381-5
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