Study Type
Interventional - Drug
ongoing
The objective of the INVICTUS study is 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 is comprised of, running concurrently:
- Two randomized, parallel group, open-label clinical trials, INVICTUS-RCT (4565 participants total).
- A multi-center INVICTUS-Registry for RVHD (17,000 participants).
Study Design
Open-label RCT; Registry
NO. of Countries
27
NO. of Sites
140
NO. of Participants
4565 RCT; 17000 Registry
Study Period
2016-2021
Sponsor
PHRI
Stuart Connolly
Senior Scientist
Stuart Connolly
Senior Scientist
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.
Gayle Lewis
Associate Program Manager
Gayle Lewis
Associate Program Manager
Gayle Lewis joined PHRI’s Arrhythmia group in 2005 to work on the RE-LY trial; she started up the AVERROES trial in 2007, which she managed until its 2010 close. In 2012, Gayle moved to PHRI’s Global Health program, where she works on various epidemiological studies including PURE, as well as the rheumatic AF treatment study, INVICTUS.
Prior to joining McMaster University, she worked in Toronto at Digital Equipment of Canada for five years and was responsible for the development, testing, implementation and training of the Canadian Automatic Quoting system (AQS) for all Sales Representatives across Canada.
Gayle has been an employee of McMaster University since 1989 when she joined the Clinical Epidemiology & Biostatistics Group, and remained on campus until 1992, at which time she relocated to the Clinical Trials Methodology Group.
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.
