Study Type
Interventional - Drug
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:
Interventional - Drug
Open-label RCT; Registry
27
140
4565 RCT; 17000 Registry
2016-2021
PHRI
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