PMID- 28438739
OWN - NLM
STAT- MEDLINE
DCOM- 20180227
LR  - 20181113
IS  - 2047-9980 (Electronic)
IS  - 2047-9980 (Linking)
VI  - 6
IP  - 4
DP  - 2017 Apr 24
TI  - Reporting Clinical End Points and Safety Events in an Acute Coronary Syndrome 
      Trial: Results With Integrated Collection.
LID - 10.1161/JAHA.117.005490 [doi]
LID - e005490
AB  - BACKGROUND: End points and adverse events (AEs) are collected separately in 
      clinical trials, yet regulatory requirements for serious AE reporting vary across 
      regions, so classifying end points according to seriousness criteria can be 
      useful in global trials. METHODS AND RESULTS: In the Apixaban for Prevention of 
      Acute Ischemic Events 2 (APPRAISE-2) trial, patients with a recent acute coronary 
      syndrome were randomized to apixaban or placebo for the prevention of recurrent 
      ischemic events. Suspected end points (myocardial infarction, stroke, or 
      bleeding) were adjudicated by an independent clinical events classification 
      committee. Safety criteria were collected for suspected end points and AEs. 
      Patient-level event rates per 100 patient-days of follow-up, modeled using 
      Poisson regression, explored the influence of region and patient characteristics 
      on event reporting. Overall, 13 909 events were reported by 858 sites in 39 
      countries; 8.4% (n=1166) were suspected end points, and 91.6% (n=12 743) were 
      AEs. Overall, 66.0% of suspected end points were confirmed by the clinical events 
      classification committee. Most clinical events classification committee-confirmed 
      end points met criteria to be classified as serious (94.0%); many clinical events 
      classification committee-negated end points also did (63.2%), but fewer AEs met 
      seriousness criteria (17.9%). The most common seriousness criterion was 
      hospitalization (79.9%, n=2594). Region explained 28.7% of end point- and 26.4% 
      of serious AE-reporting variation, and patient characteristics explained an 
      additional 25.4% of end point and 13.4% of serious AE variation. Nonserious 
      AE-reporting variation was not explained by adjustment. CONCLUSIONS: An 
      integrated collection of end points and serious AEs is feasible in a 
      multinational trial and illustrates the shared characteristics of events. 
      Tailoring event collection to fit the phase and purpose of the trial is 
      achievable and informative. CLINICAL TRIAL REGISTRATION: URL: 
      http://www.clinicaltrials.gov. Unique identifier: NCT00831441.
CI  - (c) 2017 The Authors. Published on behalf of the American Heart Association, Inc., 
      by Wiley.
FAU - Guimaraes, Patricia O
AU  - Guimaraes PO
AD  - Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
AD  - Instituto do Coracao (InCor), Hospital das Clinicas Faculdade de Medicina da 
      Universidade de Sao Paulo, Sao Paulo, Brazil.
FAU - Lopes, Renato D
AU  - Lopes RD
AD  - Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC 
      renato.lopes@duke.edu.
FAU - Stevens, Susanna R
AU  - Stevens SR
AD  - Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
FAU - Zimerman, Andre
AU  - Zimerman A
AD  - Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
FAU - Wruck, Lisa
AU  - Wruck L
AD  - Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
FAU - James, Stefan K
AU  - James SK
AD  - Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
FAU - Haque, Ghazala
AU  - Haque G
AD  - Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
FAU - Giraldez, Roberto Rocha C V
AU  - Giraldez RRCV
AD  - Instituto do Coracao (InCor), Hospital das Clinicas Faculdade de Medicina da 
      Universidade de Sao Paulo, Sao Paulo, Brazil.
FAU - Alexander, John H
AU  - Alexander JH
AD  - Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
FAU - Alexander, Karen P
AU  - Alexander KP
AD  - Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
LA  - eng
SI  - ClinicalTrials.gov/NCT00831441
PT  - Journal Article
DEP - 20170424
PL  - England
TA  - J Am Heart Assoc
JT  - Journal of the American Heart Association
JID - 101580524
RN  - 0 (Factor Xa Inhibitors)
RN  - 0 (Pyrazoles)
RN  - 0 (Pyridones)
RN  - 3Z9Y7UWC1J (apixaban)
SB  - IM
CIN - J Am Heart Assoc. 2017 Apr 24;6(4):. PMID: 28438742
MH  - Acute Coronary Syndrome/*drug therapy
MH  - Data Collection/*methods
MH  - Factor Xa Inhibitors/*therapeutic use
MH  - Hemorrhage/*chemically induced
MH  - Humans
MH  - Myocardial Infarction/*prevention & control
MH  - Pyrazoles/*therapeutic use
MH  - Pyridones/*therapeutic use
MH  - *Randomized Controlled Trials as Topic
MH  - Secondary Prevention
MH  - Stroke/*prevention & control
PMC - PMC5533035
OTO - NOTNLM
OT  - acute coronary syndrome
OT  - clinical end points
OT  - clinical events classification
OT  - safety
OT  - serious adverse events
EDAT- 2017/04/26 06:00
MHDA- 2018/02/28 06:00
PMCR- 2017/04/01
CRDT- 2017/04/26 06:00
PHST- 2017/04/26 06:00 [entrez]
PHST- 2017/04/26 06:00 [pubmed]
PHST- 2018/02/28 06:00 [medline]
PHST- 2017/04/01 00:00 [pmc-release]
AID - JAHA.117.005490 [pii]
AID - JAH32141 [pii]
AID - 10.1161/JAHA.117.005490 [doi]
PST - epublish
SO  - J Am Heart Assoc. 2017 Apr 24;6(4):e005490. doi: 10.1161/JAHA.117.005490.