Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patients undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial

Detalhes bibliográficos
Autor(a) principal: Biagioni, Rodrigo Bruno
Data de Publicação: 2020
Outros Autores: Lopes, Renato Delascio, Agati, Leandro Barile, Sacilotto, Roberto, Wolosker, Nelson, Sobreira, Marcone Lima [UNESP], de Freitas Soares, Bruno Leonardo, Joviliano, Edwaldo Edner, Bernardi, Walkiria Hueb, Junior, Valter Castelli, Caffaro, Roberto Augusto, Fioranelli, Alexandre, Van Bellen, Bonno, Casella, Ivan Benaduce, Fidelis, Ronald José Ribeiro, Flumignan, Ronald Luiz Gomes, Comerota, Anthony James, Ramacciotti, Eduardo
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da UNESP
Texto Completo: http://dx.doi.org/10.1016/j.ahj.2020.06.010
http://hdl.handle.net/11449/201152
Resumo: Background: New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. Study design: This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events – MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.
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spelling Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patients undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trialBackground: New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. Study design: This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events – MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.São Paulo State Public Servant HospitalDuke Clinical Research Institute Duke University School of MedicineScience Valley Research InstituteAlbert Einstein HospitalUniversidade Estadual Paulista (UNESP)Santa Casa de Maceio MaceioHospital das Clínicas de Ribeirão Preto São Paulo University Medical School (USP)Santa Casa de São Paulo School of Medical SciencesBeneficência Portuguesa de São PauloHospital das Clínicas de São Paulo São Paulo UniversityVascular and Endovascular Surgery–Federal University of BahiaFederal University of São PauloInova Heart and Vascular InstituteHemostasis & Thrombosis Research Laboratories at Loyola University Medical CenterUniversidade Estadual Paulista (UNESP)São Paulo State Public Servant HospitalDuke University School of MedicineScience Valley Research InstituteAlbert Einstein HospitalUniversidade Estadual Paulista (Unesp)MaceioUniversidade de São Paulo (USP)Santa Casa de São Paulo School of Medical SciencesBeneficência Portuguesa de São PauloUniversidade Federal da Bahia (UFBA)Inova Heart and Vascular InstituteHemostasis & Thrombosis Research Laboratories at Loyola University Medical CenterBiagioni, Rodrigo BrunoLopes, Renato DelascioAgati, Leandro BarileSacilotto, RobertoWolosker, NelsonSobreira, Marcone Lima [UNESP]de Freitas Soares, Bruno LeonardoJoviliano, Edwaldo EdnerBernardi, Walkiria HuebJunior, Valter CastelliCaffaro, Roberto AugustoFioranelli, AlexandreVan Bellen, BonnoCasella, Ivan BenaduceFidelis, Ronald José RibeiroFlumignan, Ronald Luiz GomesComerota, Anthony JamesRamacciotti, Eduardo2020-12-12T02:25:22Z2020-12-12T02:25:22Z2020-09-01info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/article100-106http://dx.doi.org/10.1016/j.ahj.2020.06.010American Heart Journal, v. 227, p. 100-106.1097-67440002-8703http://hdl.handle.net/11449/20115210.1016/j.ahj.2020.06.0102-s2.0-85088645446Scopusreponame:Repositório Institucional da UNESPinstname:Universidade Estadual Paulista (UNESP)instacron:UNESPengAmerican Heart Journalinfo:eu-repo/semantics/openAccess2024-09-30T17:35:13Zoai:repositorio.unesp.br:11449/201152Repositório InstitucionalPUBhttp://repositorio.unesp.br/oai/requestrepositoriounesp@unesp.bropendoar:29462024-09-30T17:35:13Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)false
dc.title.none.fl_str_mv Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patients undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial
title Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patients undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial
spellingShingle Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patients undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial
Biagioni, Rodrigo Bruno
title_short Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patients undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial
title_full Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patients undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial
title_fullStr Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patients undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial
title_full_unstemmed Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patients undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial
title_sort Rationale and design for the study Apixaban versus ClopidoGRel on a background of aspirin in patients undergoing InfraPoPliteal angioplasty for critical limb ischemia: AGRIPPA trial
author Biagioni, Rodrigo Bruno
author_facet Biagioni, Rodrigo Bruno
Lopes, Renato Delascio
Agati, Leandro Barile
Sacilotto, Roberto
Wolosker, Nelson
Sobreira, Marcone Lima [UNESP]
de Freitas Soares, Bruno Leonardo
Joviliano, Edwaldo Edner
Bernardi, Walkiria Hueb
Junior, Valter Castelli
Caffaro, Roberto Augusto
Fioranelli, Alexandre
Van Bellen, Bonno
Casella, Ivan Benaduce
Fidelis, Ronald José Ribeiro
Flumignan, Ronald Luiz Gomes
Comerota, Anthony James
Ramacciotti, Eduardo
author_role author
author2 Lopes, Renato Delascio
Agati, Leandro Barile
Sacilotto, Roberto
Wolosker, Nelson
Sobreira, Marcone Lima [UNESP]
de Freitas Soares, Bruno Leonardo
Joviliano, Edwaldo Edner
Bernardi, Walkiria Hueb
Junior, Valter Castelli
Caffaro, Roberto Augusto
Fioranelli, Alexandre
Van Bellen, Bonno
Casella, Ivan Benaduce
Fidelis, Ronald José Ribeiro
Flumignan, Ronald Luiz Gomes
Comerota, Anthony James
Ramacciotti, Eduardo
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv São Paulo State Public Servant Hospital
Duke University School of Medicine
Science Valley Research Institute
Albert Einstein Hospital
Universidade Estadual Paulista (Unesp)
Maceio
Universidade de São Paulo (USP)
Santa Casa de São Paulo School of Medical Sciences
Beneficência Portuguesa de São Paulo
Universidade Federal da Bahia (UFBA)
Inova Heart and Vascular Institute
Hemostasis & Thrombosis Research Laboratories at Loyola University Medical Center
dc.contributor.author.fl_str_mv Biagioni, Rodrigo Bruno
Lopes, Renato Delascio
Agati, Leandro Barile
Sacilotto, Roberto
Wolosker, Nelson
Sobreira, Marcone Lima [UNESP]
de Freitas Soares, Bruno Leonardo
Joviliano, Edwaldo Edner
Bernardi, Walkiria Hueb
Junior, Valter Castelli
Caffaro, Roberto Augusto
Fioranelli, Alexandre
Van Bellen, Bonno
Casella, Ivan Benaduce
Fidelis, Ronald José Ribeiro
Flumignan, Ronald Luiz Gomes
Comerota, Anthony James
Ramacciotti, Eduardo
description Background: New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. Study design: This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events – MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.
publishDate 2020
dc.date.none.fl_str_mv 2020-12-12T02:25:22Z
2020-12-12T02:25:22Z
2020-09-01
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://dx.doi.org/10.1016/j.ahj.2020.06.010
American Heart Journal, v. 227, p. 100-106.
1097-6744
0002-8703
http://hdl.handle.net/11449/201152
10.1016/j.ahj.2020.06.010
2-s2.0-85088645446
url http://dx.doi.org/10.1016/j.ahj.2020.06.010
http://hdl.handle.net/11449/201152
identifier_str_mv American Heart Journal, v. 227, p. 100-106.
1097-6744
0002-8703
10.1016/j.ahj.2020.06.010
2-s2.0-85088645446
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv American Heart Journal
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv 100-106
dc.source.none.fl_str_mv Scopus
reponame:Repositório Institucional da UNESP
instname:Universidade Estadual Paulista (UNESP)
instacron:UNESP
instname_str Universidade Estadual Paulista (UNESP)
instacron_str UNESP
institution UNESP
reponame_str Repositório Institucional da UNESP
collection Repositório Institucional da UNESP
repository.name.fl_str_mv Repositório Institucional da UNESP - Universidade Estadual Paulista (UNESP)
repository.mail.fl_str_mv repositoriounesp@unesp.br
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