2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials

被引：134

作者：

Hicks, Karen A. ^{[1
]}

Mahaffey, Kenneth W. ^{[2
]}

Mehran, Roxana ^{[3
]}

Nissen, Steven E. ^{[4
]}

Wiviott, Stephen D. ^{[5
]}

Dunn, Billy ^{[6
]}

Solomon, Scott D. ^{[7
]}

Mar-Ler, John R. ^{[6
]}

Teerlink, John R. ^{[8
,9
]}

Farb, Andrew

Morrow, David A. ^{[5
]}

Targum, Shari L. ^{[1
]}

Sila, Cathy A. ^{[10
]}

Hai, Mary T. Thanh ^{[11
]}

Jaff, Michael R. ^{[12
]}

Joffe, Hylton V. ^{[13
]}

Cutlip, Donald E. ^{[14
]}

Desai, Akshay S. ^{[7
]}

Lewis, Eldrin F. ^{[7
]}

Gibson, C. Michael ^{[15
]}

Landray, Martin J. ^{[16
,17
]}

Lincoff, A. Michael ^{[4
]}

White, Christopher J. ^{[18
]}

Brooks, Steven S. ^{[19
]}

Rosenfield, Kenneth ^{[20
]}

Domanski, Michael J. ^{[21
]}

Lansky, Alexandra J. ^{[22
]}

McMurray, John J. V. ^{[23
]}

Tcheng, James E. ^{[24
]}

Steinhubl, Steven R. ^{[25
]}

Burton, Paul ^{[26
]}

Mauri, Laura ^{[27
]}

O'Connor, Christopher M. ^{[28
]}

Pfeffer, Marc A. ^{[7
]}

Hung, H. M. James ^{[29
]}

Stockbridge, Norman L. ^{[1
]}

Chaitman, Bernard R. ^{[30
]}

Temple, Robert J. ^{[31
]}

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Off Drug Evaluat 1, Div Cardiovasc & Renal Prod, 10903 New Hampshire Ave,Bldg 22,Room 4182, Silver Spring, MD 20993 USA

[2] Stanford Univ, Sch Med, Dept Med, Stanford Ctr Clin Res, Stanford, CA USA

[3] Icahn Sch Med Mt Sinai, Div Cardiol, New York, NY USA

[4] Cleveland Clin, Dept Cardiovasc Med, Cleveland, OH USA

[5] Brigham & Womens Hosp, TIMI Study Grp, Cardiovasc Div, Boston, MA USA

[6] US FDA, Ctr Drug Evaluat & Res, Off Drug Evaluat 1, Div Neurol Prod, Silver Spring, MD USA

[7] Brigham & Womens Hosp, Cardiovasc Div, Boston, MA USA

[8] Univ Calif San Francisco, San Francisco Vet Affairs Med Ctr, Sect Cardiol, San Francisco, CA USA

[9] Univ Calif San Francisco, Sch Med, San Francisco, CA USA

[10] Univ Hosp, Cleveland Med Ctr, Neurol Inst, Cleveland, OH USA

[11] US FDA, Ctr Drug Evaluat & Res, Off Drug Evaluat 2, Silver Spring, MD USA

[12] Harvard Med Sch, Dept Med, Boston, MA USA

[13] US FDA, Ctr Drug Evaluat & Res, Off Drug Evaluat 3, Div Bone Reprod & Urol Prod, Silver Spring, MD USA

[14] Harvard Med Sch, Beth Israel Deaconess Med Ctr, Dept Med, Cardiol Div, Boston, MA USA

[15] Harvard Med Sch, Dept Med, Cardiovasc Div, Boston, MA USA

[16] Univ Oxford, Clin Trial Serv Unit, Oxford, England

[17] Univ Oxford, Epidemiol Studies Unit CTSU, Oxford, England

[18] Ochsner Clin Sch, Dept Cardiol, New Orleans, LA USA

[19] Brooks Medtech LLC, Reisterstown, MD USA

[20] Massachusetts Gen Hosp, Corrigan Minehan Heart Ctr, Vasc Med & Intervent, Boston, MA 02114 USA

[21] Univ Toronto, Mt Sinai Hosp, Univ Hlth Network, Peter Munk Cardiac Ctr, Toronto, ON, Canada

[22] Yale Sch Med, Cardiol Sect, Dept Internal Med, New Haven, CT USA

[23] Univ Glasgow, BHF Cardiovasc Res Ctr, Inst Cardiovasc & Med Sci, Glasgow, Lanark, Scotland

[24] Duke Univ, Med Ctr, Div Cardiovasc Med, Durham, NC USA

[25] Scripps Translat Sci Inst, Div Digital Med, La Jolla, CA USA

[26] Janssen Pharmaceut Inc, Cardiovasc & Metab Med Affairs, Titusville, NJ USA

[27] Harvard Med Sch, Brigham & Womens Hosp, Dept Med, Cardiovasc Div, Boston, MA USA

[28] Inova Heart & Vasc Inst, Div Cardiol, Falls Church, VA USA

[29] US FDA, Ctr Drug Evaluat & Res, Div Biometr 1, Off Biostat, Silver Spring, MD USA

[30] St Louis Univ, Sch Med, Ctr Comprehens Cardiovasc Care, St Louis, MO 63103 USA

[31] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD USA

来源：

CIRCULATION | 2018年 / 137卷 / 09期

基金：

英国医学研究理事会; 美国国家卫生研究院;

关键词：

cardiovascular and stroke endpoint definitions; cardiovascular and stroke outcome definitions; cardiovascular and stroke outcomes; cardiovascular endpoint definitions; cardiovascular endpoints; cardiovascular outcomes; clinical trial endpoint definitions; clinical trial endpoints; endpoint definitions; endpoints; outcome definitions; stroke endpoint definitions; stroke endpoints; stroke outcomes; TRANSIENT ISCHEMIC ATTACK; HEALTH-CARE PROFESSIONALS; CARDIAC TROPONIN-T; MYOCARDIAL-INFARCTION; HEART-FAILURE; CONSENSUS DOCUMENT; COMMITTEE; INTERVENTION; MORTALITY; STATEMENT;

D O I：

10.1161/CIRCULATIONAHA.117.033502

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the US Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials.

引用

页码：961 / 972

页数：12

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