Study Type
Interventional - Drug
completed
The objective of the MANAGE trial was to assess the impact of dabigatran (a direct thrombin inhibitor) in patients suffering myocardial injury after noncardiac surgery (MINS).
In addition, a partial 2×2 factorial design was used to randomize patients not already on a proton pump inhibitor to either omeprazole or matching placebo.
The trial intended to determine the effect of dabigatran 110 mg versus matching placebo on the risk of major vascular complications, and the effect of omeprazole 20 mg versus matching placebo on the risk of major upper gastrointestinal complications in patients who have suffered MINS. Patients were followed-up for an average of one year post-randomization.
Primary endpoints:
- Major vascular complication (composite of vascular mortality
- Nonfatal myocardial infarction
- Nonfatal stroke
- Nonfatal peripheral arterial thrombosis
- Nonfatal symptomatic pulmonary embolism
Secondary endpoint:
Major upper gastrointestinal complication (composite of overt gastroduodenal bleeding, overt upper gastrointestinal bleeding of unknown origin, or upper gastrointestinal perforation)
MANAGE Main Results 2018 - Download PDFStudy Design
Multicentre, international, 2x2 partial factorial RCT
NO. of Countries
21
NO. of Sites
115
NO. of Participants
1042
Study Period
2013-2018
Sponsor
PHRI
PJ Devereaux on MANAGE at ESC 2018
PJ Devereaux
Deputy Director, Senior Scientist
PJ Devereaux
Deputy Director, Senior Scientist
Devereaux is a cardiologist, perioperative care physician, and clinical epidemiologist. He is the Director of the Division of Perioperative Care at McMaster University and a Deputy Director, Senior Scientist, and Scientific Leader of the Anesthesiology, Perioperative Medicine, and Surgical Research Group at PHRI. He is the Nominated Principal Applicant of the Accelerating Clinical Trials (ACT) Consortium, which is the Pan-Canadian Clinical Trials Consortium funded by the Canadian Institutes of Health Research (CIHR). Additionally, he holds a Tier 1 Canadian Research Chair in Perioperative Medicine.
Devereaux is a full Professor at McMaster University and the President of the Society of Perioperative Research and Care. He has published over 450 peer-reviewed papers and more than 85 book chapters, editorials, and commentaries, including 17 in the New England Journal of Medicine, 13 in the Lancet, and 11 in JAMA. He has an h-index of 115 and has given over 1000 lectures and research presentations in 41 countries. His research program focuses on major vascular complications during and after surgery, and he has led many large international randomized trials and prospective cohort studies on this topic.
Jessica Vincent
Program Director
Jessica Vincent
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.
