Study Type
Interventional - Drug
POISE-3 was an international multicentre randomized clinical trial to assess the impact of tranexamic acid (TXA) versus placebo, and to assess the impact of managing hypotension versus standard of care (hypertension) in patients undergoing non-cardiac surgery who are at risk of a perioperative cardiovascular event.
The primary objective of POISE-3 was to determine the incidence of a composite of myocardial infarction, stroke and pulmonary embolism. Patients were followed for one year.
ACC22 - Tranexamic Acid - Download PDF ACC22 - Hypo/hypertension strategies - Download PDF POISE-3 Rationale - Download PDFInterventional - Drug
Multi-centre, blinded, randomized controlled trial
24
149
9561
2018 - 2022
PHRI
Senior Scientist
PJ Devereaux is Senior Scientific Lead, Perioperative and Surgery, PHRI, Professor and University Scholar in the Departments of Health Research Methods, Evidence, and Impact (HEI) and Medicine at McMaster University, and Director of the Division of Cardiology at McMaster.
The focus of his clinic research is vascular complications around the time of surgery, leading several large, international RCTs and observational studies addressing this issue. He has published more than 250 peer-reviewed papers and more than 50 book chapters and editorials. He is supported by a Tier 1 Canadian Research Chair in Perioperative Medicine, and holds the Yusuf Chair in Cardiology at McMaster University.
Scientist
Maura Marcucci is a scientist in the Perioperative and Surgery research group at PHRI, and an Assistant Professor, Department of Medicine, and Department of Health Research Methods, Evidence, and Impact, at McMaster University. Leveraging on her background in vascular medicine, thrombosis and hemostasis disorders, and geriatrics, Maura’s current main focus of clinical research is cardiovascular and neurocognitive outcomes in noncardiac surgery. She is currently the project officer of the PeriOperative ISchemic Evaluation (POISE)-3 trial and principal investigator of the POISE-3 sub-study on delirium and cognitive decline.
She obtained her medical training and residency in Internal Medicine in Italy. In 2012-2013 she completed an MSc in Health Research Methodology and a clinical fellowship in Hematology/Medicine at McMaster University. In 2014-2016 she was an Assistant Professor at the University of Milan in Italy, before returning to Hamilton, Canada.
Senior Scientist
David Conen is a Scientist at PHRI, which he joined in 2016, and an Associate Professor, Department of Medicine, McMaster University. A trained internist and cardiologist from Basel, Switzerland, he obtained a Master of Public Health degree from Harvard University.
His research activities involves the conduct of large epidemiological cohort studies to study risk factors for the occurrence of atrial fibrillation and its consequences, and research into therapies to prevent and treat perioperative atrial fibrillation. David is the Co-Principal Investigator of a large national cohort study to assess the relationship between atrial fibrillation and cognitive decline in Switzerland (Swiss-AF). He has published more than 130 peer-reviewed manuscripts in leading scientific journals as well as several reviews and editorials.
Scientist
Andre Lamy is a cardiac surgeon practicing at the Hamilton Health Sciences since 1996, and Professor in the Department of Surgery, McMaster University. He led the Canadian Institute of Health Research funded CORONARY trial, which evaluated off-pump CABG surgery versus on-pump CABG surgery in 4752 patients. The results were published in the New England Journal of Medicine in 2012 and 2013.
Scientist
Flavia Borges is a Scientist in the perioperative and surgery research group at PHRI, and internist, and an Assistant Professor, Department of Medicine (perioperative care; general internal medicine), McMaster University. Her research is focused on perioperative cardiac biomarkers, and perioperative strategies to improve clinical outcomes in patients undergoing noncardiac surgery.
She undertook her Masters in Health Sciences and her PhD in Cardiovascular Sciences in Brazil, and a research and clinical perioperative vascular fellowship under the direction of PJ Devereaux at McMaster. She holds an Early Career Research Award from McMaster.
Investigator
Sandra Ofori is an Investigator in the Perioperative and Surgery research group at PHRI, an Assistant Professor in McMaster University’s Department of Medicine (cardiology), and a PhD candidate in the Health Research Methodology program under the supervision of PJ Devereaux. Her research interests are in the areas of perioperative care and cardiovascular disease prevention.
Her current research program is focused on perioperative smoking cessation and strategies to improve long-term health in patients undergoing noncardiac surgery. Ofori is actively involved in the conduct of large international perioperative clinical trials coordinated from PHRI and was the project officer of the Post Discharge after Surgery Virtual Care with Remote Automated Monitoring Technology (PVC-RAM) Trial.
Ofori completed her residency training in Internal Medicine and Cardiology at the University of Port Harcourt, Nigeria, where she was an Assistant Professor and Consultant Cardiologist in the College of Health Sciences and its affiliated teaching hospital. She also has a Master’s degree in Preventive Cardiology from the Imperial College, London UK, and was in the third cohort of the World Heart Federation Salim Yusuf Emerging Leaders Program that was focused on the reduction of the global burden of hypertension.
Investigator
Michael Ke Wang is an Investigator at PHRI and an MSc student in the Health Research Methodology Program at McMaster University, supervised by Dr. David Conen. His main interests are in perioperative medicine and perioperative atrial fibrillation. Michael is actively involved in the conduct of large international perioperative clinical trials coordinated from PHRI; he is the project officer of the COP-AF and ASPIRE-AF trials.
Michael is a Clinical Scholar in the Division of General Internal Medicine at McMaster University. He obtained his medical degree from the University of Ottawa and completed his internal medicine residency, general internal medicine fellowship, and perioperative vascular training at McMaster University.
Investigator
Pavel Roshanov, an internal medicine physician and nephrologist, is completing a fellowship in kidney transplantation at McMaster University. He has published more than 50 papers in the areas of perioperative care and medical informatics.
Director, Statistics; Senior Scientist
Shrikant Bangdiwala, PhD, has extensive experience in the design, conduct and analysis of multi-center observational and experimental studies, having worked on clinical and community-based randomized controlled trials in congestive heart failure, cardiovascular risk factors, functional bowel disease, and obesity prevention. His statistical research interests include non-parametric methods, methodology for clinical trials, reliability and validity of diagnostic tests, and graphical methods for descriptive analyses.
A Professor in McMaster University’s Department of Health Research Methods, Evidence and Impact, he is a former Fulbright senior specialist in global public health, and holds faculty positions in universities in Chile, South Africa and India.
He is a member of the USA NIH National Institute of Allergy and Infectious Diseases (NIAID) “COVID-19 Preventive mAb Data and Safety Monitoring Board” (DSMB) that will be reviewing and monitoring the US government-supported clinical trials of candidate preventive monoclonal Antibodies for SARS-CoV-2 and COVID-19. He also chairs the Multinational DSMB for the division of AIDS at NIH, and is a member of the Gastrointestinal Drugs Advisory Committee of the FDA.
Scientist
Richard Whitlock is Associate Chair, Research, and a Professor at the Department of Surgery, McMaster University. He was awarded the inaugural Canada Research Chair in Cardiovascular Surgery in 2020.
As well as being a PHRI Scientist, Richard is a cardiac surgeon and intensive care physician at Hamilton Health Sciences. His clinical focus is on aortic valve intervention and aortic surgery. He is a lead investigator for the CIHR funded studies SIRS, LAAOS III, and TRICS III, which have established a network of more than 120 centres to address important questions in his field.
He has published more than 90 articles in referred journals. Medically qualified at the University of Toronto, Richard received his specialist training in cardiac surgery and critical care medicine at McMaster University. In 2012, he received his PhD in clinical epidemiology.
Senior Scientist
John Eikelboom is Associate Professor in the Department of Medicine, McMaster University, and a haematologist in the Thrombosis Service, Hamilton General Hospital. He originally trained in Internal Medicine and Haematology in Perth, Australia and subsequently moved to Hamilton to take up a Tier II Canada Research Chair in Cardiovascular Medicine.
He has co-authored more than 350 articles in peer-reviewed journals. His current research, supported by the Canadian Institutes for Health Research, the Heart and Stroke Foundation and the National Health and Medical Research Council of Australia, focuses on the efficacy and safety of antithrombotic therapies, outcomes after blood transfusion and bleeding, and the mechanisms of variable response to antiplatelet drugs.
Statistical Operations Manager
Kumar Balasubramanian has been an integral part of the PHRI Statistics department since November 2013 when he joined as a Statistical Analyst; then became Statistical Analyst II in 2016, and Statistical Coordinator in 2018. In August 2021 he became the department’s Statistical Operations Manager.
Before coming to PHRI, Kumar held academic statistical positions at University of Calgary and University of Toronto. He holds a Masters in Biostatistics from University of Toronto.
Executive Director; Senior Scientist
Salim Yusuf is an internationally renowned cardiologist and epidemiologist, whose work over 40 years has substantially influenced prevention and treatment of cardiovascular disease. Born in India, medically qualified at St. John’s Medical College, Bangalore in 1976, he received a Rhodes Scholarship and obtained a DPhil from Oxford, during which he (along with Richard Peto, Rory Collins and Peter Sleight) initiated the concepts of large, simple trials, and meta-analysis. He proposed the concept of combination drug treatment for prevention of CVD to achieve large reductions in CVD with a single pill (now called the polypill concept), but more importantly has been evaluating the concept through large randomized trials.
He leads several global studies involving more than 60 countries in every inhabited continent of the world aimed at enhancing knowledge about the biological, behavioural and societal causes, consequences, and approaches to the control of heart diseases, and strokes through large multi-country programs such as INTERHEART, INTERSTROKE, and PURE.
He holds a Heart and Stroke Foundation of Ontario Research Chair and has received (among others) the Lifetime Research Achievement award of the Canadian Cardiovascular Society; the Paul Wood Silver Medal of the British Cardiac Society; the European Society of Cardiology gold medal, the clinical Research Prize of the American Heart Association and the International Award and the Braunwald Lecture of the American College of Cardiology. He has been inducted into the Royal Society of Canada and the Canadian Medical Hall of Fame; been appointed as an Officer of the Order of Canada, and received the Canada Gairdner Wightman Award in 2014. He has received four honorary doctorates, and is among the top 20 most cited health researchers in history.
Salim Yusuf has published more than 1,000 articles in refereed journals, rising to the second most cited researcher in the world for 2011. He has mentored more than 120 scientists, several of whom are in leadership positions across the globe. He has been President of the World Heart Federation (2015-2016), where he initiated several programs (the Emerging Leaders program, road maps for CVD control and a course for training primary care practitioners in CVD prevention) aimed at halving the CVD burden globally within a generation. The World Heart Federation has recognized his contributions by naming the program the Salim Yusuf Emerging Leaders Programme.
He is a Distinguished University Professor of Medicine, and Executive Director of the Population Health Research Institute, McMaster University and Chief Scientist, Hamilton Health Sciences.
Scientist
Emilie Belley-Côté is an Assistant Professor in the Department of Medicine at McMaster University; she practices critical care cardiology in the cardiovascular intensive care unit and coronary care unit at the Hamilton General Hospital. Her research interests include perioperative cardiac surgery care, knowledge synthesis and guideline development. At this stage in her career, she has more than 120 publications, including articles in NEJM, Lancet, JAMA, as well as first-tier critical care journals.
She obtained her MD from Université de Sherbrooke in 2006. After internal medicine and cardiology training, as well as an MSc in Clinical Sciences, she completed a critical care fellowship at McMaster. In 2019, she completed a PhD in Health Research Methodology at McMaster University.
Scientist
William McIntyre is an Assistant Professor (cardiology), Department of Medicine, McMaster University, a cardiologist at Hamilton Health Sciences, and an Investigator in the Arrhythmia and Heart Failure research program at PHRI. His research interests include atrial fibrillation – including screening, detection and cardioversion, cardiac devices and methods in randomized clinical trials.
He holds fellowship awards from CIHR and the Canadian Stroke Prevention Intervention Network (C-SPIN). He holds research grants from the Canadian Cardiovascular Society (CCS) Atrial Fibrillation Awards Program and the Heart and Stroke Foundation of Canada. William has published 150 peer-reviewed articles, and was the 2018 Recipient of the CCS Trainee Excellence in Education Award. He completed Medical School and Internal Medicine Residency at Queen’s University, and his adult cardiology residency at the University of Manitoba.
Associate Scientist
Emmanuelle Duceppe is a principal scientist with Centre hospitalier de l’Université de Montréal (CHUM) Research Centre in Montreal, Quebec. She is also an internist and clinical assistant professor, Department of Medicine, Université de Montréal.
Her research interests include: prediction of preoperative risk in non-cardiac surgery; perioperative interventions and clinical outcomes in non-cardiac surgery; biomarkers for prediction and early identification of perioperative complications; pre- and postoperative management of patients in day surgery; statistical methodology for predictive model development; and cohort studies and clinical trials.
Associate Scientist
Amit Garg is the Associate Dean, Clinical Research, at the Schulich School of Medicine & Dentistry, Western University, has practiced as a staff nephrologist at the London Health Sciences Centre in London, Ontario, Canada since 2003, and is a Professor of Medicine, Epidemiology and Biostatistics at Western University, with a cross-appointment in the Department of Health Research Methods, Evidence, and Impact (HEI) at McMaster University. A past president of the Canadian Society of Nephrology, Amit Garg serves as the current Ontario Lead of the Kidney, Dialysis and Transplantation Program at ICES.
He values his ongoing collaborations with PJ Devereaux and other leading clinician-scientists at PHRI, which has led to several sub-studies funded by the Canadian Institutes of Health Research which examined the effects of perioperative interventions on the risk of acute kidney injury (off-pump cardiopulmonary bypass surgery) in the CORONARY study, and more. A current interest is in pragmatic randomized trials embedded into routine healthcare delivery.
Scientist
Michael McGillion is Associate Professor, and Assistant Dean, Research, at the School of Nursing, McMaster University. He is the Heart and Stroke Foundation/Michael G. DeGroote Endowed Chair in Cardiovascular Nursing Research, and the International Visiting Professor of Digital Health, at Coventry University in the UK.
He is an internationally-recognized researcher in the area of persistent forms of cardiac pain such as refractory angina and unrelieved chest pain following successful revascularization procedures. He was Chair of the Joint Canadian Cardiovascular Society – Canadian Pain Society guidelines for the management of refractory angina, funded by the Canadian Institutes of Health Research (CIHR). He is Principal Investigator of the largest CIHR-funded, international prospective cohort study to examine social and psychological predictors of chronic post-surgical pain following cardiac surgery. His research focuses on remote automated monitoring and virtual recovery support for people recovering from cardiac and vascular surgery, decision support for people living with RFA, and global-scale, web-based dissemination of new evidence on persistent forms of cardiac pain.
Mike has been recognized for his research and advocacy by receiving the Canadian Pain Society Early Career Award and the McMaster University Arch Award for outstanding contributions to society; and was the first University Scholar (2019) from the McMaster School of Nursing.
Program Director
Jessica Vincent has more than 15 years’ experience in coordinating and managing large, international clinical trials. As Associate Program Manager, she oversees interventional trials, registries, and observational research studies in the areas of perioperative medicine, cardiac surgery, and digital health.
She holds an Honours Bachelor of Science Degree from Queens University, and a Master of Clinical Epidemiology Degree from the University of Newcastle.
Senior Research Coordinator
Ingrid Copland has been working in research for McMaster University since 1991. She has been at PHRI for 23 years where she has coordinated large, international, industry and investigator initiated trials. Since 2014 she has been with the perioperative and surgery department coordinating observational, drug and device trials.
These organizations were involved in this study as: grant providers; funders (including in-kind); national leaders not directly involved in the research team, and other supporters.
Research highlights, events, media coverage of PHRI and more.
April 4, 2022
PHRI Scientist Maura Marcucci presented today at ACC 2022 on the arm of the POISE-3 trial looking at blood pressure...
Read MoreApril 4, 2022
Banner image © ACC/Nick Agro 2022 Day 1 (April 2) at ACC 2022 was a big day for PHRI researchers....
Read MoreApril 2, 2022
Event photos courtesy ©ACC/Nick Agro 2022 The large, international trial, POISE-3, has found a drug that helps the blood to...
Read MoreData will be shared as per the PHRI Data Sharing Policy, which requires approval of the proposed use of the data by a review committee.
We wanted to undertake a large international factorial RCT to establish the effects of rosuvastatin...
The objective of the POISE-2 study was to determine the impact of clonidine versus placebo...
The objective of the POISE study was to evaluate the effects of metoprolol (a beta-blocker...
Back To Top
Don't miss out on the latest health research news from the Population Health Research Institute in Hamilton, Canada