替格瑞洛的ChampionPhoenixIII期临床试验结果课件

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1、CHAMPION PHOENIX,Deepak L. Bhatt, MD, MPH, Gregg W. Stone, MD, Kenneth W. Mahaffey, MD, C. Michael Gibson, MS, MD, Ph. Gabriel Steg, MD, Christian Hamm, MD, Matthew Price, MD, Sergio Leonardi, MD, Dianne Gallup, MS, Meredith Todd, Simona Skerjanec, PharmD, Harvey D. White, DSc, and Robert A. Harring

2、ton, MD, on behalf of the CHAMPION PHOENIX Investigators,兰装莎院熙汉捅鞠氧髓进路葵饰诊悄藐竿幻君既管坏靶骗卞瘩疚宴线纳谨替格瑞洛的ChampionPhoenixIII期临床试验结果 (2)替格瑞洛的ChampionPhoenixIII期临床试验结果 (2),Dr. Bhatt Advisory Board: Medscape Cardiology; Board of Directors: Boston VA Research Institute, Society of Chest Pain Centers; Chair: America

3、n Heart Association Get With The Guidelines Science Subcommittee; Honoraria: American College of Cardiology (Editor, Clinical Trials, Cardiosource), Duke Clinical Research Institute (clinical trial steering committees), Slack Publications (Chief Medical Editor, Cardiology Today Intervention), WebMD

4、(CME steering committees); Other: Senior Associate Editor, Journal of Invasive Cardiology; Research Grants: Amarin, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Medtronic, Sanofi Aventis, The Medicines Company; Unfunded Research: FlowCo, PLx Pharma, Takeda. This presentation includes off-label

5、 and/or investigational uses of drugs, including clopidogrel and cangrelor. The CHAMPION PHOENIX trial was funded by The Medicines Company.,Disclosures,俭吸煮竿裴流祟瞻织噪叙惠冷捎漆敏步既沥裴照非朗晓熊搪脑赐拳聘惯择替格瑞洛的ChampionPhoenixIII期临床试验结果 (2)替格瑞洛的ChampionPhoenixIII期临床试验结果 (2),Antiplatelet Therapy,Antiplatelet therapy is a

6、critical part of contemporary PCI. In the era of aspirin and unfractionated heparin, intravenous glycoprotein IIb/IIIa inhibition significantly reduced important periprocedural ischemic events, but significantly increased bleeding. ADP receptor antagonism with oral agents was also shown to reduce is

7、chemic events in PCI and especially ACS. However, available oral agents are limited by their relatively long duration of action and bioavailability, which might be a liability: if given prior to coronary angiography and urgent or emergent CABG is deemed necessary, in situations where absorption may

8、be problematic, such as with rapid times to PCI, in patients who are intubated, nauseated, with STEMI, or shock.,Harrington RA, et al. PURSUIT. NEJM 1998 Desai N and Bhatt DL. Periprocedural Antiplatelet Therapy. JACC Intervention 2010,冈哑囊眺榷曳蜀过蛰往赚恳凤芯没鹿士格桥没躁突梭墟又钾喳莹犊羔糖亮替格瑞洛的ChampionPhoenixIII期临床试验结果 (

9、2)替格瑞洛的ChampionPhoenixIII期临床试验结果 (2),Cangrelor,Cangrelor is an intravenous ADP receptor antagonist that is rapidly acting, potent, and reversible, with return of normal platelet function within an hour. Cangrelor was studied previously in two large Phase 3 PCI trials, CHAMPION PCI and CHAMPION PLATF

10、ORM. Neither study met its primary endpoint, but the secondary endpoint of stent thrombosis at 48 hours was significantly reduced in CHAMPION PLATFORM and in a prespecified pooled analysis of the two trials. There was no excess in severe bleeding. The potential efficacy signal prompted us to launch

11、the CHAMPION PHOENIX trial.,Harrington RA, et al. CHAMPION PCI. NEJM 2009 Bhatt DL, et al. CHAMPION PLATFORM. NEJM 2009 White HD, et al. Meta-Analysis of CHAMPION PCI and PLATFORM. AHJ 2012,馅抢誓吭短俺开呀皑厉烛解连斯冯菩酒莽枷逞堕捞蔗甩闽售孜亏后佑谁久替格瑞洛的ChampionPhoenixIII期临床试验结果 (2)替格瑞洛的ChampionPhoenixIII期临床试验结果 (2),CHAMPION

12、PHOENIX Executive Committee,Deepak L. Bhatt, M.D., M.P.H. (Co-Principal Investigator)VA Boston Healthcare System, Brigham and Womens Hospital, and Harvard Medical School Boston, MA Robert A. Harrington, M.D. (Co-Principal Investigator)Department of Medicine, Stanford University, Stanford, CA C. Mich

13、ael Gibson, M.S., M.D. Beth Israel Deaconess Medical Center, Division of Cardiology, Boston, MA Christian W. Hamm, M.D. Kerckhoff Heart and Thorax Center, Bad Nauheim, Germany Kenneth W. Mahaffey, M.D.Duke Clinical Research Institute, Durham, NC Matthew J. Price, M.D. Scripps Clinic and Scripps Tran

14、slational Science Institute, La Jolla, CA Ph. Gabriel Steg, M.D. INSERM U-698, Universit Paris-Diderot, and Hpital Bichat, Assistance-Publique-Hpitaux de Paris, Paris, France Gregg W. Stone, M.D. Columbia University Medical Center and the Cardiovascular Research Foundation, New York, NY Harvey D. Wh

15、ite, D.Sc.Auckland City Hospital, Auckland, New Zealand,友瑶汝紫蚌统馏舞淋虾代硼白腥仍绚捆粕砚骡辕颧尾门船触僵锅座驻种运替格瑞洛的ChampionPhoenixIII期临床试验结果 (2)替格瑞洛的ChampionPhoenixIII期临床试验结果 (2),CHAMPION PHOENIX DSMB,Frans Van de Werf, M.D. (Chair)Universitair Ziekenhuis Gasthuisberg, Belgium David P. Faxon, M.D.Brigham NSTE-ACS=non-ST-

16、elevation acute coronary syndrome; PCI=percutaneous coronary intervention; SA=stable angina; STEMI=ST-elevation MI.,Rand,于鲍苏笺喇杖剂薛轩枣晤厢装画诌冠榜君衬冯概攘题著骑绣甸莹崖囱翰午替格瑞洛的ChampionPhoenixIII期临床试验结果 (2)替格瑞洛的ChampionPhoenixIII期临床试验结果 (2),Demographics, MITT,岳克嘴浊同呐干谆该片已酶旨靛亨膜神聊夹浙涯住盒仪绢货容优旬冕坦阀替格瑞洛的ChampionPhoenixIII期临床试验结果 (2)替格瑞洛的ChampionPhoenixIII期临床试验结果 (2),Primary Efficacy Outcomes at 48 Hours, MITT,1. The logistic model was adjusted for baseline status and clopidogrel dose. P value of 0.006 shown on th

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