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 consists of a randomized-controlled trial (RCT) of 4500 patients comparing rivaroxaban with vitamin K antagonists (VKA) in patients with RHD and atrial fibrillation (AF), and a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry. It uses a multicentre, randomized, open-label, parallel group trial design to test whether rivaroxaban 20 mg given once daily is non-inferior (or superior) to VKA in patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area≤2cm2, left atrial spontaneous echo-contrast or thrombus, or a CHA2DS2VASc score≥2).
Prof Zühlke is the South African National leader and co-principal investigator (PI) at the Groote Schuur Hospital site. She is additionally the site PI at Red Cross Children's Hospital where paediatric participants are recruited for the registry arm of the study.