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Defining high bleed...
Defining high bleeding risk in patients undergoing percutaneous coronary intervention : a consensus document from the Academic Research Consortium for High Bleeding Risk
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- Urban, Philip (author)
- La Tour Hosp, Geneva, Switzerland;Cardiovasc European Res Ctr, Massy, France
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- Mehran, Roxana (author)
- Icahn Sch Med Mt Sinai, New York, NY 10029 USA
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- Colleran, Roisin (author)
- Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany
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- Angiolillo, Dominick J. (author)
- Univ Florida, Coll Med, Div Cardiol, Jacksonville, FL USA
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- Byrne, Robert A. (author)
- Tech Univ Munich, Deutsch Herzzentrum Munchen, Munich, Germany
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- Capodanno, Davide (author)
- Ctr Alte Special & Trapianti, Cardiothoracvasc Dept, Catania, Italy;Univ Catania, Azienda Osped Univ Vittorio Emanuele Policlin, Catania, Italy
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- Cuisset, Thomas (author)
- Aix Marseille Univ, Fac Med, CHU Timone, Dept Cardiol, Marseille, France;Aix Marseille Univ, Fac Med, INSERM, Inra,Ctr Rech Cardiovasc & Nutr, Marseille, France
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- Cutlip, Donald (author)
- Harvard Med Sch, Cardiol Div, Beth Israel Deaconess Med Ctr, Boston, MA 02115 USA
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- Eerdmans, Pedro (author)
- DEKRA Certificat BV, Notified Body, Hamilton, ON, Canada
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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 GmbH, Stadt Kliniken Neuss, Neuss, Germany
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- James, Stefan, 1964- (author)
- Uppsala universitet,Kardiologi,Uppsala kliniska forskningscentrum (UCR)
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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, Dept Cardiovasc Med, Grad Sch Med, Kyoto, Japan
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- Konishi, Akihide (author)
- Pharmaceut & Med Devices Agcy, Off Med Devices 1, Tokyo, Japan
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- Laschinger, John (author)
- US FDA, Silver Spring, MD USA
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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, Pf 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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- Ls, Stuart Pocock (author)
- London Sch Hyg & Trop Med, London, England
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- Price, Matthew J. (author)
- Scripps Clin, La Jolla, CA USA
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- Rao, Sunil, V (author)
- Duke Clin Res Inst, Durham, NC USA
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- Spitzer, Ernest (author)
- Erasmus Univ, Thoraxctr, Med Ctr, 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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- Windhoevel, Ute (author)
- Cardiovasc European Res Ctr, Massy, France
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- Yeh, Robert W. (author)
- Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA
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- Krucoff, Mitchell W. (author)
- Duke Clin Res Inst, Durham, NC USA;Duke Univ, Med Ctr, Durham, NC USA
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- Morice, Marie-Claude (author)
- Cardiovasc European Res Ctr, Massy, France
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(creator_code:org_t)
- 2019-05-22
- 2019
- English.
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In: European Heart Journal. - : Oxford University Press (OUP). - 0195-668X .- 1522-9645. ; 40:31, s. 2632-2653
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Abstract
Subject headings
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- Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Keyword
- clinical trial protocols as topic
- hemorrhage
- percutaneous coronary intervention
Publication and Content Type
- ref (subject category)
- art (subject category)
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To the university's database
- By the author/editor
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Urban, Philip
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Mehran, Roxana
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Colleran, Roisin
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Angiolillo, Domi ...
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Byrne, Robert A.
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Capodanno, David ...
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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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Laschinger, John
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Leon, Martin B.
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Magee, Pf Adrian
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Mitsutake, Yoshi ...
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Mylotte, Darren
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Ls, Stuart Pococ ...
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Price, Matthew 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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Windhoevel, Ute
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Yeh, Robert W.
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Krucoff, Mitchel ...
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Morice, Marie-Cl ...
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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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European Heart J ...
- By the university
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Uppsala University