TY - JOUR
T1 - Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post–myocardial infarction patients (TIGRIS) study
AU - for the TIGRIS Study Investigators
AU - Westermann, Dirk
AU - Goodman, Shaun G.
AU - Nicolau, José C.
AU - Requena, Gema
AU - Maguire, Andrew
AU - Chen, Ji Yan
AU - Granger, Christopher B.
AU - Grieve, Richard
AU - Pocock, Stuart J.
AU - Blankenberg, Stefan
AU - Vega, Ana Maria
AU - Yasuda, Satoshi
AU - Simon, Tabassome
AU - Brieger, David
N1 - Funding Information:
The authors thank the patients, their families, and all investigators involved in this study. Assistance with project management, site management, data management, and regulatory affairs was provided by Worldwide Clinical Trials Evidence Group, Nottingham, England, United Kingdom. Medical writing support was provided by Carl V. Felton, PhD, of Prime, Knutsford, England, United Kingdom, in accordance with Good Publication Practice guidelines and funded by AstraZeneca. AstraZeneca was involved in the study design, collection, analysis, and interpretation of data, as well as data checking of information provided in the manuscript. However, ultimate responsibility for opinions, conclusions, and data interpretation lies with the authors.
Publisher Copyright:
© 2017 Wiley Periodicals, Inc.
PY - 2017/12
Y1 - 2017/12
N2 - The long-term progression of coronary artery disease as defined by the natural disease course years after a myocardial infarction (MI) is an important but poorly studied area of clinical research. The long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post–myocardial infarction patients (TIGRIS) study was designed to address this knowledge gap by evaluating patient management and clinical outcomes following MI in different regions worldwide. TIGRIS (ClinicalTrials.gov Identifier: NCT01866904) is a multicenter, observational, prospective, longitudinal study enrolling patients with history of MI 1 to 3 years previously and high risk of developing atherothrombotic events in a general-practice setting. The primary objective of TIGRIS is to evaluate clinical events (time to first occurrence of any event from the composite cardiovascular endpoint of MI, unstable angina with urgent revascularization, stroke, or death from any cause), and healthcare resource utilization associated with hospitalization for these events (hospitalization duration and procedures) during follow-up. Overall, 9225 patients were enrolled between June 2013 and November 2014 and are being followed in 369 different centers worldwide. This will allow for the description of regional differences in patient characteristics, risk profiles, medical treatment patterns, clinical outcomes, and healthcare resource utilization. Patients will be followed for up to 3 years. Here we report the rationale, design, patient distribution, and selected baseline characteristics of the TIGRIS study. TIGRIS will describe real-world management, quality of life (self-reported health), and healthcare resource utilization for patients with stable coronary artery disease ≥1 year post-MI.
AB - The long-term progression of coronary artery disease as defined by the natural disease course years after a myocardial infarction (MI) is an important but poorly studied area of clinical research. The long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post–myocardial infarction patients (TIGRIS) study was designed to address this knowledge gap by evaluating patient management and clinical outcomes following MI in different regions worldwide. TIGRIS (ClinicalTrials.gov Identifier: NCT01866904) is a multicenter, observational, prospective, longitudinal study enrolling patients with history of MI 1 to 3 years previously and high risk of developing atherothrombotic events in a general-practice setting. The primary objective of TIGRIS is to evaluate clinical events (time to first occurrence of any event from the composite cardiovascular endpoint of MI, unstable angina with urgent revascularization, stroke, or death from any cause), and healthcare resource utilization associated with hospitalization for these events (hospitalization duration and procedures) during follow-up. Overall, 9225 patients were enrolled between June 2013 and November 2014 and are being followed in 369 different centers worldwide. This will allow for the description of regional differences in patient characteristics, risk profiles, medical treatment patterns, clinical outcomes, and healthcare resource utilization. Patients will be followed for up to 3 years. Here we report the rationale, design, patient distribution, and selected baseline characteristics of the TIGRIS study. TIGRIS will describe real-world management, quality of life (self-reported health), and healthcare resource utilization for patients with stable coronary artery disease ≥1 year post-MI.
KW - Coronary artery disease
KW - Healthcare resource utilization
KW - Observational
KW - Trial design
KW - myocardial infarction < Ischemic heart disease
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U2 - 10.1002/clc.22837
DO - 10.1002/clc.22837
M3 - Article
C2 - 29247524
AN - SCOPUS:85038073103
VL - 40
SP - 1197
EP - 1204
JO - Clinical Cardiology
JF - Clinical Cardiology
SN - 0160-9289
IS - 12
ER -