Stroke is a devastating and decapitating outcome of Atrial Fibrillation (AF). AF affects 1-2% of the general population and it’s the most frequently encountered arrhythmia in clinical practice. Although any valvular pathology can be related to AF, stenotic left-sided valvular lesions (and in particular rheumatic heart disease) have the highest prevalence rates. Investigation Of Rheumatic Atrial Fibrillation Treatment Using Vitamin K Antagonist, Rivaroxaban Or Aspirin Studies (Invictus). CRENC is in charge of the INVICTUS Trial in Cameroon.

Invictus is a clinical trial that is a comprehensive evaluation of Rheumatic Valvular Heart Disease (RVHD), AF/Atrial Flutter and stroke. It is aimed at investigating the efficiency of RIVAROXABAN (New Oral Anticoagulant- NOAC) in prevention of stroke in patients with RVHD in AF/Atrial Flutter, compared to VKAs and Aspirin.  It is going to consist of;

• A multi-centre hospital based registry.
• A prospective, randomised, parallel, open-label clinical trial of rivaroxaban versus VKAs therapy to show that rivaroxaban has advantages over VKAs (non-inferiority), with testing of its superiority if non-inferiority is satisfied.
• A prospective, randomised, parallel, open-label superiority trial comparing rivaroxaban to aspirin in patients with very high-risk factors unsuitable for VKA.

This trial will include all consenting patients ≥18 years with RVHD confirmed on echocardiography, increase risk of stroke (CHA2DS2-VASs score ≥2), AF/Atrial Flutter documented in the 6 months prior to enrolment, confirmed with 12-lead ECG and or Holter ECG.

Meanwhile it will exclude all non-consenting patients, other health and socio-economic conditions that may interfere with the trial and patients with contraindications to study medication of trial.

Patient will be randomly assigned trial medication, and the drugs will be known (open-label). Patients will be followed up at 6 months and 1-year intervals. Adverse effects (especially bleeding) and outcomes (especially stroke) will be strictly followed up and addressed if any.

Coordinating Institution: Population Health Research Institute, Canada

National Coordination organization: CRENC

National study Coordinator and National Principal Investigator: Dr TANTCHOU Cabral M.D., Ph.D; Cardiologist

Douala General Hospital site PI & Master National Leader for PHRI: Anastase Dzudie, MD, PhD, FESC.

Douala General Hospital site  coordinator: Muluh Magha Irene (RA)