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 RVHD, 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 Children's Hospital where paediatric participants will be recruited for the registry arm of the study.