2017 cardiovascular and stroke endpoint definitions for clinical trials

Karen A. Hicks
Kenneth W. Mahaffey
Roxana Mehran
Steven E. Nissen
Stephen D. Wiviott
Billy Dunn
Scott Solomon
John R. Marler
John R. Teerlink
Andrew Farb
David A. Morrow
Shari L. Targum
Cathy A. Sila
Mary T.T. Hai
Michael R. Jaff
Hylton V. Joffe
Donal E. Cutlip
Akshay S. Desai
Eldrin F. Lewis
C. Michael Gibson
Martin J. Landray
A. M. Lincoff
Christopher White
Steven S. Brooks
Kenneth A. Rosenfield
Michael J. Domanski
Alexandra J. Lansky
John McMurray
James E. Tcheng
Steven R. Steinhubl
Paul R. Burton
Laura Mauri
Christopher M. O'Connor
Marc A. Pfeffer
James Hung
Norman L. Stockbridge
Bernard Chaitman
Robert J. Temple

Abstract

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.