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Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel.
Capodanno, Davide; Morice, Marie-Claude; Angiolillo, Dominick J; Bhatt, Deepak L; Byrne, Robert A; Colleran, Roisin; Cuisset, Thomas; Cutlip, Donald; Eerdmans, Pedro; Eikelboom, John; Farb, Andrew; Gibson, C Michael; Gregson, John; Haude, Michael; James, Stefan K; Kim, Hyo-Soo; Kimura, Takeshi; Konishi, Akihide; Leon, Martin B; Magee, P F Adrian; Mitsutake, Yoshiaki; Mylotte, Darren; Pocock, Stuart J; Rao, Sunil V; Spitzer, Ernest; Stockbridge, Norman; Valgimigli, Marco; Varenne, Olivier; Windhovel, Ute; Krucoff, Mitchel W; Urban, Philip; Mehran, Roxana.
Afiliação
  • Capodanno D; Division of Cardiology, Azienda Ospedaliero Universitario "Policlinico G. Rodolico-San Marco", University of Catania, Catania, Italy. Electronic address: dcapodanno@unict.it.
  • Morice MC; Cardiovascular European Research Center, Massy, France. Electronic address: https://twitter.com/mc_morice.
  • Angiolillo DJ; Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.
  • Bhatt DL; Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/DLBhattMD.
  • Byrne RA; Cardiovascular Research Institute Dublin, Mater Private Hospital, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland. Electronic address: https://twitter.com/robebyrne.
  • Colleran R; Cardiovascular Research Institute Dublin, Mater Private Hospital, Dublin, Ireland; Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
  • Cuisset T; Département de Cardiologie, Centre Hospitalier Universitaire Timone and Inserm, Inra, Centre de Recherche en Cardiovasculaire et Nutrition, Faculté de Médecine, Aix-Marseille Université, Marseille, France. Electronic address: https://twitter.com/CuissetDr.
  • Cutlip D; Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/DonaldCutlip.
  • Eerdmans P; DEKRA Certification, Arnhem, the Netherlands.
  • Eikelboom J; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
  • Farb A; U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Gibson CM; Harvard Medical School, Boston, Massachusetts; Baim Institute for Clinical Research, Brookline, Massachusetts. Electronic address: https://twitter.com/CMichaelGibson.
  • Gregson J; London School of Hygiene and Tropical Medicine, London, United Kingdom.
  • Haude M; Städtische Kliniken Neuss, Lukaskrankenhaus, Neuss, Germany.
  • James SK; Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
  • Kim HS; Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
  • Kimura T; Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
  • Konishi A; Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
  • Leon MB; Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address: https://twitter.com/MartyMleon.
  • Magee PFA; U.S. Food and Drug Administration, Silver Spring, Maryland. Electronic address: https://twitter.com/dmylotte.
  • Mitsutake Y; Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
  • Mylotte D; University Hospital and National University of Ireland, Galway, Ireland.
  • Pocock SJ; London School of Hygiene and Tropical Medicine, London, United Kingdom.
  • Rao SV; Duke Clinical Research Institute, Durham, North Carolina. Electronic address: https://twitter.com/SVRaoMD.
  • Spitzer E; Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Cardialysis, Clinical Trial Management and Core Laboratories, Rotterdam, the Netherlands. Electronic address: https://twitter.com/ernest_spitzer.
  • Stockbridge N; U.S. Food and Drug Administration, Silver Spring, Maryland.
  • Valgimigli M; Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: https://twitter.com/vlgmrc.
  • Varenne O; Service de Cardiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France; Université Paris Descartes, Sorbonne Paris-Cité, Paris, France.
  • Windhovel U; Cardiovascular European Research Center, Massy, France. Electronic address: https://twitter.com/Urphi.
  • Krucoff MW; Duke Clinical Research Institute, Durham, North Carolina; Duke University Medical Center, Durham, North Carolina. Electronic address: https://twitter.com/mwkrucoff.
  • Urban P; La Tour Hospital, Geneva, Switzerland.
  • Mehran R; Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: https://twitter.com/Drroxmehran.
J Am Coll Cardiol ; 76(12): 1468-1483, 2020 09 22.
Article em En | MEDLINE | ID: mdl-32943165
Investigating the balance of risk for thrombotic and bleeding events after percutaneous coronary intervention (PCI) is especially relevant for patients at high bleeding risk (HBR). The Academic Research Consortium for HBR recently proposed a consensus definition in an effort to standardize the patient population included in HBR trials. The aim of this consensus-based document, the second initiative from the Academic Research Consortium for HBR, is to propose recommendations to guide the design of clinical trials of devices and drugs in HBR patients undergoing PCI. The authors discuss the designs of trials in HBR patients undergoing PCI and various aspects of trial design specific to HBR patients, including target populations, intervention and control groups, primary and secondary outcomes, and timing of endpoint reporting.
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Texto completo: 1 Base de dados: MEDLINE Assunto principal: Ensaios Clínicos como Assunto / Intervenção Coronária Percutânea / Hemorragia Tipo de estudo: Etiology_studies / Guideline / Risk_factors_studies Limite: Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Ensaios Clínicos como Assunto / Intervenção Coronária Percutânea / Hemorragia Tipo de estudo: Etiology_studies / Guideline / Risk_factors_studies Limite: Humans Idioma: En Ano de publicação: 2020 Tipo de documento: Article