Investigation of Rheumatic AF Treatment using Vitamin K Antagonists, Rivaroxaban
Funder: Bayer AG
The INVICTUS programme, initiated in 2016, builds upon the 2014 REMEDY pilot study of 3,343 RHD patients from 14 countries. INVICTUS is a comprehensive evaluation of rheumatic valvular heart disease (RVHD), atrial fibrillation (AF)/flutter and stroke. It uses a prospective, randomized, open-label superiority trial design in comparing rivaroxaban to aspirin in high-risk patients either with AF and unsuitable for VKA or without AF and with high risk factors.
The global INVICTUS programme is comprised of a registry of 20,000 participants and two clinical trials. The first trial, with participants in rheumatic valvular atrial fibrillation or flutter (AF/flutter), will test whether rivaroxaban is non-inferior to vitamin K antagonists (VKAs) for prevention of stroke or systemic embolism (the Non-inferiority Trial). In the second trial, in participants with RHD, either with AF/flutter but unsuitable for VKA therapy, or with sinus rhythm but with high risk, whether rivaroxaban is superior to aspirin for prevention of stroke or systemic embolism (the Superiority Trial). A/Prof Zühlke is the South African National leader and co-principal investigator (PI) at Groote Schuur Hospital. She is additionally the site PI at Red Cross Hospital where paediatric participants will be recruited for the registry arm of the study.