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Trial Design Princi...
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Capodanno, DavideUniv Catania, Azienda Osped Univ Policlin G Rodolico San Marco, Div Cardiol, Catania, Italy.
(author)
Trial Design Principles for Patients a High Bleeding Risk Undergoing PCI JACC Scientific Expert Panel
- Article/chapterEnglish2020
Publisher, publication year, extent ...
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ELSEVIER SCIENCE INC,2020
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printrdacarrier
Numbers
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LIBRIS-ID:oai:DiVA.org:uu-423245
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https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-423245URI
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https://doi.org/10.1016/j.jacc.2020.06.085DOI
Supplementary language notes
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Language:English
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Summary in:English
Part of subdatabase
Classification
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Subject category:ref swepub-contenttype
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Subject category:art swepub-publicationtype
Notes
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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. (C) 2020 by the American College of Cardiology Foundation.
Subject headings and genre
Added entries (persons, corporate bodies, meetings, titles ...)
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Morice, Marie-ClaudeCardiovasc European Res Ctr, Massy, France.
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Angiolillo, Dominick J.Univ Florida, Coll Med, Div Cardiol, Jacksonville, FL USA.
(author)
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Bhatt, Deepak L.Harvard Med Sch, Brigham & Womens Hosp, Heart & Vasc Ctr, Boston, MA 02115 USA.
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Byrne, Robert A.Mater Private Hosp, Cardiovasc Res Inst Dublin, Dublin, Ireland.;Royal Coll Surgeons Ireland, Sch Pharm & Biomol Sci, Dublin, Ireland.
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Colleran, RoisinMater Private Hosp, Cardiovasc Res Inst Dublin, Dublin, Ireland.;Tech Univ Munich, Deutsches Herzzentrum Munchen, Munich, Germany.
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Cuisset, ThomasAix Marseille Univ, CHU Timone, Dept Cardiol, Marseille, France.;Aix Marseille Univ, Fac Med, Ctr Rech Cardiovasc & Nutr, INRA,INSERM, Marseille, France.
(author)
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Cutlip, DonaldHarvard Med Sch, Beth Israel Deaconess Med Ctr, Cardiol Div, Boston, MA 02115 USA.
(author)
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Eerdmans, PedroDEKRA Certificat, Arnhem, Netherlands.
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Eikelboom, JohnMcMaster Univ, Dept Med, Hamilton, ON, Canada.
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Farb, AndrewUS FDA, Silver Spring, MD USA.
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Gibson, C. MichaelHarvard Med Sch, Boston, MA 02115 USA.;Baim Inst Clin Res, Brookline, MA USA.
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Gregson, JohnLondon Sch Hyg & Trop Med, London, England.
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Haude, MichaelLukaskrankenhaus, Stadt Kliniken Neuss, Neuss, Germany.
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James, Stefan,1964-Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Institutionen för medicinska vetenskaper(Swepub:uu)stjam367
(author)
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Kim, Hyo-SooSeoul Natl Univ Hosp, Cardiovasc Ctr, Seoul, South Korea.
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Kimura, TakeshiKyoto Univ, Grad Sch Med, Dept Cardiovasc Med, Kyoto, Japan.
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Konishi, AkihidePharmaceut & Med Devices Agcy, Off Med Devices 1, Tokyo, Japan.
(author)
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Leon, Martin B.Columbia Univ, Med Ctr, New York, NY USA.;Cardiovasc Res Fdn, New York, NY USA.
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Magee, P. F. AdrianUS FDA, Silver Spring, MD USA.
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Mitsutake, YoshiakiPharmaceut & Med Devices Agcy, Off Med Devices 1, Tokyo, Japan.
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Mylotte, DarrenUniv Hosp, Galway, Ireland.;Natl Univ Ireland, Galway, Ireland.
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Pocock, Stuart J.London Sch Hyg & Trop Med, London, England.
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Rao, Sunil V.Duke Clin Res Inst, Durham, NC USA.
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Spitzer, ErnestErasmus MC, Thoraxctr, Rotterdam, Netherlands.;Clin Trial Management & Core Labs, Cardialysis, Rotterdam, Netherlands.
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Stockbridge, NormanUS FDA, Silver Spring, MD USA.
(author)
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Valgimigli, MarcoUniv Bern, Dept Cardiol, Inselspital, Bern, Switzerland.
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Varenne, OlivierHop Cochin, AP HP, Serv Cardiol, Paris, France.;Univ Paris 05, Sorbonne Paris Cite, Paris, France.
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Windhovel, UteCardiovasc European Res Ctr, Massy, France.
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Krucoff, Mitchel W.Duke Clin Res Inst, Durham, NC USA.;Duke Univ, Med Ctr, Durham, NC USA.
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Urban, PhilipLa Tour Hosp, Geneva, Switzerland.
(author)
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Mehran, RoxanaIcahn Sch Med Mt Sinai, New York, NY 10029 USA.
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Univ Catania, Azienda Osped Univ Policlin G Rodolico San Marco, Div Cardiol, Catania, Italy.Cardiovasc European Res Ctr, Massy, France.
(creator_code:org_t)
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In:Journal of the American College of Cardiology: ELSEVIER SCIENCE INC76:12, s. 1468-14830735-10971558-3597
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Capodanno, David ...
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Morice, Marie-Cl ...
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Angiolillo, Domi ...
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Bhatt, Deepak L.
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Byrne, Robert A.
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Colleran, Roisin
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Cuisset, Thomas
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Cutlip, Donald
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Eerdmans, Pedro
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Eikelboom, John
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Farb, Andrew
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Gibson, C. Micha ...
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Gregson, John
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Haude, Michael
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James, Stefan, 1 ...
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Kim, Hyo-Soo
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Kimura, Takeshi
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Konishi, Akihide
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Leon, Martin B.
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Magee, P. F. Adr ...
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Mitsutake, Yoshi ...
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Mylotte, Darren
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Pocock, Stuart J ...
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Rao, Sunil V.
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Spitzer, Ernest
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Stockbridge, Nor ...
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Valgimigli, Marc ...
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Varenne, Olivier
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Windhovel, Ute
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Krucoff, Mitchel ...
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Urban, Philip
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Mehran, Roxana
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