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
Autor(a) principal: | |
---|---|
Data de Publicação: | 2020 |
Outros Autores: | , , , , , , , , , , , , , , , , |
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. |
id |
UNSP_6afa3a0c5cde192508213e473664d4dd |
---|---|
oai_identifier_str |
oai:repositorio.unesp.br:11449/201152 |
network_acronym_str |
UNSP |
network_name_str |
Repositório Institucional da UNESP |
repository_id_str |
2946 |
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 |
_version_ |
1813546422816997376 |