Study Type
Interventional - Drug
completed
The objective of the INVICTUS study was to determine if:
1. In patients with rheumatic valvular heart disease (RVHD) and who are in atrial fibrillation or flutter (AF/flutter) and have other stroke risk factors, rivaroxaban is non-inferior to vitamin K antagonists (VKAs) for prevention of stroke or systemic embolism.
2. In patients with RVHD, either with AF/flutter but unsuitable for VKA therapy, or with sinus rhythm but with high risk, rivaroxaban is superior to aspirin for prevention of stroke or systemic embolism.
Primary endpoints:
Stroke and systemic embolism.
This research program was comprised of running concurrently two randomized, parallel group, open-label clinical trials, and a multi-center registry for RVHD.
G. Karthikeyan
The national leader in India for INVICTUS, G. Karthikeyan, presented results at ESC 2022.
INVICTUS - ESC 2022 (download PDF)Study Design
Open-label RCT and registry
NO. of Countries
24
NO. of Sites
148
NO. of Participants
13866
Study Period
2016 - 2022
Sponsor
PHRI
Stuart Connolly
Stuart Connolly
Stuart Connolly is a Professor of Medicine at McMaster University and a cardiac electrophysiologist at Hamilton Health Sciences. He became a faculty member at McMaster University in 1983 and was awarded a full professorship in 1994. He was also appointed as the inaugural holder of the Salim Yusuf Chair in Cardiology at McMaster University.
He has published more than 270 scientific articles in the field, and is currently a member of the editorial boards for a number of prominent cardiology journals, including Heart, the American Heart Journal and the Journal of Pacing and Electrophysiology. His main research interests are focused on the evaluation of treatments for heart rhythm disorders. His academic career has been largely devoted to the design and execution of controlled clinical trials in this area.
He holds a Masters degree from Fordham University, New York, and an MD from McGill University in Montreal. He received his specialist training in cardiology at the University of Toronto and at Stanford University.
Sumathy Rangarajan
Program Director
Sumathy Rangarajan
Program Director
Sumathy Rangarajan has been Program Director, Global Health, since 2016, preceded by many years’ service at PHRI in other roles. She oversees the PURE study team, as well as the INVICTUS rheumatic AF treatment trial, the CANPWR pediatric weight management registry, and others.
She holds both a Bachelor of Science Degree and a Master of Science degree from Pune University in India.
Divya Pattath
Project Manager
Divya Pattath
Project Manager
Divya Pattath has been with the Global Health team at PHRI since 2013, and has experience with managing large, international investigator-initiated clinical trials, observational studies and registries.
Divya holds a Masters Degree in Industrial Biotechnology and Enterprise from University of Bath, UK and Applied Clinical Research Certificate from McMaster University.
Amy Krol
Project Manager
Amy Krol
Project Manager
Amy Krol has been employed by the Population Health Research Institute over the last 19 years where she has worked on a number of large, international, industry-sponsored trails. For the past six years, she has focused her efforts on coordinating site management for the INVICTUS study, an investigator-initiated rheumatic AF trial & registry.
She holds a Bachelor of Science Degree (Honours Biology) from Wilfrid Laurier University and a Clinical Research Associate Certificate from McMaster University.
Gayle Lewis
Gayle Lewis
Bayer
VIDEO: G. Karthikeyan on INVICTUS at ESC 2022
