Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI,Journal of the American College of Cardiology

当前位置： X-MOL 学术 › J. Am. Coll. Cardiol. › 论文详情

Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)

Trial Design Principles for Patients at High Bleeding Risk Undergoing PCI
Journal of the American College of Cardiology ( IF 24.0 ) Pub Date : 2020-09-01 , DOI: 10.1016/j.jacc.2020.06.085
Davide Capodanno ₁ , Marie-Claude Morice ₂ , Dominick J Angiolillo ₃ , Deepak L Bhatt ₄ , Robert A Byrne ₅ , Roisin Colleran ₆ , Thomas Cuisset ₇ , Donald Cutlip ₈ , Pedro Eerdmans ₉ , John Eikelboom ₁₀ , Andrew Farb ₁₁ , C Michael Gibson ₁₂ , John Gregson ₁₃ , Michael Haude ₁₄ , Stefan K James ₁₅ , Hyo-Soo Kim ₁₆ , Takeshi Kimura ₁₇ , Akihide Konishi ₁₈ , Martin B Leon ₁₉ , P F Adrian Magee ₁₁ , Yoshiaki Mitsutake ₁₈ , Darren Mylotte ₂₀ , Stuart J Pocock ₁₃ , Sunil V Rao ₂₁ , Ernest Spitzer ₂₂ , Norman Stockbridge ₁₁ , Marco Valgimigli ₂₃ , Olivier Varenne ₂₄ , Ute Windhovel ₂ , Mitchel W Krucoff ₂₅ , Philip Urban ₂₆ , Roxana Mehran ₂₇

Affiliation

Division of Cardiology, Azienda Ospedaliero Universitario "Policlinico G. Rodolico-San Marco", University of Catania, Catania, Italy.
Cardiovascular European Research Center, Massy, France.
Division of Cardiology, University of Florida College of Medicine, Jacksonville, Florida.
Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, Massachusetts.
Cardiovascular Research Institute Dublin, Mater Private Hospital, Dublin, Ireland; School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, Dublin, Ireland.
Cardiovascular Research Institute Dublin, Mater Private Hospital, Dublin, Ireland; Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.
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.
Cardiology Division, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.
DEKRA Certification, Arnhem, the Netherlands.
Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
U.S. Food and Drug Administration, Silver Spring, Maryland.
Harvard Medical School, Boston, Massachusetts; Baim Institute for Clinical Research, Brookline, Massachusetts.
London School of Hygiene and Tropical Medicine, London, United Kingdom.
Städtische Kliniken Neuss, Lukaskrankenhaus, Neuss, Germany.
Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
Cardiovascular Center, Seoul National University Hospital, Seoul, Korea.
Department of Cardiovascular Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Office of Medical Devices 1, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
University Hospital and National University of Ireland, Galway, Ireland.
Duke Clinical Research Institute, Durham, North Carolina.
Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Cardialysis, Clinical Trial Management and Core Laboratories, Rotterdam, the Netherlands.
Department of Cardiology, Inselspital, University of Bern, Bern, Switzerland.
Service de Cardiologie, Hôpital Cochin, Assistance Publique - Hôpitaux de Paris, Paris, France; Université Paris Descartes, Sorbonne Paris-Cité, Paris, France.
Duke Clinical Research Institute, Durham, North Carolina; Duke University Medical Center, Durham, North Carolina.
La Tour Hospital, Geneva, Switzerland.
Icahn School of Medicine at Mount Sinai, New York, New York.

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.

中文翻译：

接受 PCI 的高出血风险患者的试验设计原则

调查经皮冠状动脉介入治疗 (PCI) 后血栓形成和出血事件风险的平衡对于高出血风险 (HBR) 患者尤其重要。HBR 学术研究联盟最近提出了一个共识定义，以努力使 HBR 试验中包含的患者群体标准化。这份基于共识的文件是 HBR 学术研究联盟的第二个倡议，其目的是提出建议，以指导在接受 PCI 的 HBR 患者中设计设备和药物的临床试验。作者讨论了接受 PCI 的 HBR 患者的试验设计以及针对 HBR 患者的试验设计的各个方面，包括目标人群、干预组和对照组、主要和次要结果以及终点报告的时间安排。

更新日期：2020-09-01

点击分享查看原文

点击收藏

阅读更多本刊最新论文本刊介绍/投稿指南

全部期刊列表>>