Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI: JACC Scientific Expert Panel.

Clinical Trials as Topic Hemorrhage Humans Outcome Assessment, Health Care Percutaneous Coronary Intervention
high bleeding risk percutaneous coronary intervention trial design

Journal

Journal of the American College of Cardiology
ISSN: 1558-3597
Titre abrégé: J Am Coll Cardiol
Pays: United States
ID NLM: 8301365

Informations de publication

Date de publication:
22 09 2020
Historique:
received: 27 05 2020
accepted: 26 06 2020
entrez: 18 9 2020
pubmed: 19 9 2020
medline: 2 2 2021
Statut: ppublish

Résumé

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.

Identifiants

DOI: 10.1016/j.jacc.2020.06.085 PMID: 32943165
pubmed: 32943165
pii: S0735-1097(20)36111-8
doi: 10.1016/j.jacc.2020.06.085
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

1468-1483

Subventions

Organisme : British Heart Foundation
ID : FS/20/25/34983
Pays : United Kingdom

Informations de copyright

Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Auteurs

Davide Capodanno (D)

Division of Cardiology, Azienda Ospedaliero Universitario "Policlinico G. Rodolico-San Marco", University of Catania, Catania, Italy. Electronic address: dcapodanno@unict.it.

Marie-Claude Morice (MC)

Cardiovascular European Research Center, Massy, France. Electronic address: https://twitter.com/mc_morice.

Dominick J Angiolillo (DJ)

Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.

Deepak L Bhatt (DL)

Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/DLBhattMD.

Robert A 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.

Roisin Colleran (R)

Cardiovascular Research Institute Dublin, Mater Private Hospital, Dublin, Ireland; Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

Thomas 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.

Donald Cutlip (D)

Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. Electronic address: https://twitter.com/DonaldCutlip.

Pedro Eerdmans (P)

DEKRA Certification, Arnhem, the Netherlands.

John Eikelboom (J)

Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Andrew Farb (A)

U.S. Food and Drug Administration, Silver Spring, Maryland.

C Michael Gibson (CM)

Harvard Medical School, Boston, Massachusetts; Baim Institute for Clinical Research, Brookline, Massachusetts. Electronic address: https://twitter.com/CMichaelGibson.

John Gregson (J)

London School of Hygiene and Tropical Medicine, London, United Kingdom.

Michael Haude (M)

Städtische Kliniken Neuss, Lukaskrankenhaus, Neuss, Germany.

Stefan K James (SK)

Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.

Hyo-Soo Kim (HS)

Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.

Takeshi Kimura (T)

Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.

Akihide Konishi (A)

Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

Martin B Leon (MB)

Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York. Electronic address: https://twitter.com/MartyMleon.

P F Adrian Magee (PFA)

U.S. Food and Drug Administration, Silver Spring, Maryland. Electronic address: https://twitter.com/dmylotte.

Yoshiaki Mitsutake (Y)

Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.

Darren Mylotte (D)

University Hospital and National University of Ireland, Galway, Ireland.

Stuart J Pocock (SJ)

London School of Hygiene and Tropical Medicine, London, United Kingdom.

Sunil V Rao (SV)

Duke Clinical Research Institute, Durham, North Carolina. Electronic address: https://twitter.com/SVRaoMD.

Ernest 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.

Norman Stockbridge (N)

U.S. Food and Drug Administration, Silver Spring, Maryland.

Marco Valgimigli (M)

Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland. Electronic address: https://twitter.com/vlgmrc.

Olivier Varenne (O)

Service de Cardiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France; Université Paris Descartes, Sorbonne Paris-Cité, Paris, France.

Ute Windhovel (U)

Cardiovascular European Research Center, Massy, France. Electronic address: https://twitter.com/Urphi.

Mitchel W Krucoff (MW)

Duke Clinical Research Institute, Durham, North Carolina; Duke University Medical Center, Durham, North Carolina. Electronic address: https://twitter.com/mwkrucoff.

Philip Urban (P)

La Tour Hospital, Geneva, Switzerland.

Roxana Mehran (R)

Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: https://twitter.com/Drroxmehran.

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Classifications MeSH

questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Trial Design Principles for Patients at High...
questionsmedicales.fr › États, signes et symptômes pathologiques › Processus pathologiques › Hémorragie › Trial Design Principles for Patients at High...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › Trial Design Principles for Patients at High...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Trial Design Principles for Patients at High...
questionsmedicales.fr › Procédures de chirurgie opératoire › Interventions chirurgicales mini-invasives › Procédures endovasculaires › Intervention coronarienne percutanée › Trial Design Principles for Patients at High...