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Trial Design Princi...
Trial Design Principles for Patients a High Bleeding Risk Undergoing PCI JACC Scientific Expert Panel
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- Capodanno, Davide (author)
- Univ Catania, Azienda Osped Univ Policlin G Rodolico San Marco, Div Cardiol, Catania, Italy.
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- Morice, Marie-Claude (author)
- Cardiovasc European Res Ctr, Massy, France.
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- Angiolillo, Dominick J. (author)
- Univ Florida, Coll Med, Div Cardiol, Jacksonville, FL USA.
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- Bhatt, Deepak L. (author)
- Harvard Med Sch, Brigham & Womens Hosp, Heart & Vasc Ctr, Boston, MA 02115 USA.
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- Byrne, Robert A. (author)
- Mater Private Hosp, Cardiovasc Res Inst Dublin, Dublin, Ireland.;Royal Coll Surgeons Ireland, Sch Pharm & Biomol Sci, Dublin, Ireland.
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- Colleran, Roisin (author)
- Mater Private Hosp, Cardiovasc Res Inst Dublin, Dublin, Ireland.;Tech Univ Munich, Deutsches Herzzentrum Munchen, Munich, Germany.
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- Cuisset, Thomas (author)
- Aix Marseille Univ, CHU Timone, Dept Cardiol, Marseille, France.;Aix Marseille Univ, Fac Med, Ctr Rech Cardiovasc & Nutr, INRA,INSERM, Marseille, France.
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- Cutlip, Donald (author)
- Harvard Med Sch, Beth Israel Deaconess Med Ctr, Cardiol Div, Boston, MA 02115 USA.
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- Eerdmans, Pedro (author)
- DEKRA Certificat, Arnhem, Netherlands.
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- Eikelboom, John (author)
- McMaster Univ, Dept Med, Hamilton, ON, Canada.
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- Farb, Andrew (author)
- US FDA, Silver Spring, MD USA.
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- Gibson, C. Michael (author)
- Harvard Med Sch, Boston, MA 02115 USA.;Baim Inst Clin Res, Brookline, MA USA.
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- Gregson, John (author)
- London Sch Hyg & Trop Med, London, England.
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- Haude, Michael (author)
- Lukaskrankenhaus, Stadt Kliniken Neuss, Neuss, Germany.
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- James, Stefan, 1964- (author)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR),Institutionen för medicinska vetenskaper
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- Kim, Hyo-Soo (author)
- Seoul Natl Univ Hosp, Cardiovasc Ctr, Seoul, South Korea.
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- Kimura, Takeshi (author)
- Kyoto Univ, Grad Sch Med, Dept Cardiovasc Med, Kyoto, Japan.
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- Konishi, Akihide (author)
- Pharmaceut & Med Devices Agcy, Off Med Devices 1, Tokyo, Japan.
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- Leon, Martin B. (author)
- Columbia Univ, Med Ctr, New York, NY USA.;Cardiovasc Res Fdn, New York, NY USA.
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- Magee, P. F. Adrian (author)
- US FDA, Silver Spring, MD USA.
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- Mitsutake, Yoshiaki (author)
- Pharmaceut & Med Devices Agcy, Off Med Devices 1, Tokyo, Japan.
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- Mylotte, Darren (author)
- Univ Hosp, Galway, Ireland.;Natl Univ Ireland, Galway, Ireland.
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- Pocock, Stuart J. (author)
- London Sch Hyg & Trop Med, London, England.
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- Rao, Sunil V. (author)
- Duke Clin Res Inst, Durham, NC USA.
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- Spitzer, Ernest (author)
- Erasmus MC, Thoraxctr, Rotterdam, Netherlands.;Clin Trial Management & Core Labs, Cardialysis, Rotterdam, Netherlands.
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- Stockbridge, Norman (author)
- US FDA, Silver Spring, MD USA.
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- Valgimigli, Marco (author)
- Univ Bern, Dept Cardiol, Inselspital, Bern, Switzerland.
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- Varenne, Olivier (author)
- Hop Cochin, AP HP, Serv Cardiol, Paris, France.;Univ Paris 05, Sorbonne Paris Cite, Paris, France.
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- Windhovel, Ute (author)
- Cardiovasc European Res Ctr, Massy, France.
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- Krucoff, Mitchel W. (author)
- Duke Clin Res Inst, Durham, NC USA.;Duke Univ, Med Ctr, Durham, NC USA.
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- Urban, Philip (author)
- La Tour Hosp, Geneva, Switzerland.
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- Mehran, Roxana (author)
- Icahn 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)
- ELSEVIER SCIENCE INC, 2020
- 2020
- English.
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In: Journal of the American College of Cardiology. - : ELSEVIER SCIENCE INC. - 0735-1097 .- 1558-3597. ; 76:12, s. 1468-1483
- Related links:
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https://doi.org/10.1...
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Abstract
Subject headings
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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
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- high bleeding risk
- percutaneous coronary intervention
- trial design
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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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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show more...
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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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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cardiac and Card ...
- Articles in the publication
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Journal of the A ...
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Uppsala University