The INVICTUS rheumatic heart disease research program: Rationale, design and baseline characteristics of a randomized trial of rivaroxaban compared to vitamin K antagonists in rheumatic valvular disease and atrial fibrillation - 19/06/20
, Stuart J Connolly, MD, FRCPC b, Mpiko Ntsekhe c, Alexander Benz, MD b, Sumathy Rangarajan, MSc b, Gayle Lewis b, Yan Yun, Msc b, Sanjib Kumar Sharma, MD d, Fathi Maklady, MD e, Alaa Eldin Elghamrawy, MD e, Khawar Kazmi, MD f, Tantchou T J Cabral, MD, PhD g, Hu Dayi, MD h, Ma Changsheng, MD h, Bernard M Gitura, MMed i, Alvaro Avezum, MD, PhD j, Liesl Zuhlke, MD, PhD k, Peter Lwabi, MMed l, Abraham Haileamlak, MD m, Okechukwu Ogah, MBBS, PhD n, Pilly Chillo, MD o, Maria Paniagua, MD p, Ahmed ElSayed, MD q, Antonio Dans, MD r, Lillian Gondwe-Chunda, MBBS s, Onkabetse Julia Molefe-Baikai, MMed t, Jesus A Gonzalez-Hermosillo, MD u, James Hakim, MMed v, Albertino Damasceno, PhD w, Emmanuel R Kamanzi, MMed x, John Musuku, MMed y, Kairat Davletov, MD, PhD z, Katherine Connolly, MD b, Bongani M Mayosi, MD, D Phil c, 1, Salim Yusuf, D Phil, FRCPC bfor the
INVICTUS Investigators
Abstract |
Background |
Rheumatic heart disease (RHD) is a neglected disease affecting 33 million people, mainly in low and middle income countries. Yet very few large trials or registries have been conducted in this population. The INVICTUS program of research in RHD 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), 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. This paper describes the rationale, design, organization and baseline characteristics of the RCT and a summary of the design of the registry and its sub-study. Patients with RHD and AF are considered to be at high risk of embolic strokes, and oral anticoagulation with VKAs is recommended for stroke prevention. But the quality of anticoagulation with VKA is poor in developing countries. A drug which does not require monitoring, and which is safe and effective for preventing stroke in patients with valvular AF, would fulfill a major unmet need.
Methods |
The INVestIgation of rheumatiC AF Treatment Using VKAs, rivaroxaban or aspirin Studies (INVICTUS-VKA) trial is an international, multicentre, randomized, open-label, parallel group trial, testing 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 ≤2 cm2, left atrial spontaneous echo-contrast or thrombus, or a CHA2DS2VASc score ≥2). The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding. The trial has enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America. The Registry plans to enroll an additional 17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years. The pregnancy sub-study will document the clinical course of pregnant women with RHD.
Conclusion |
INVICTUS is the largest program of clinical research focused on a neglected cardiovascular disease and will provide new information on the clinical course of patients with RHD, and approaches to anticoagulation in those with concomitant AF.
Le texte complet de cet article est disponible en PDF.Plan
Vol 225
P. 69-77 - juillet 2020 Retour au numéro
Article précédent
- Effect on thromboprophylaxis among hospitalized patients using a system-wide multifaceted quality improvement intervention: Rationale and design for a multicenter cluster randomized clinical trial in China
- Fen Dong, Kaiyuan Zhen, Zhu Zhang, Chaozeng Si, Jiefeng Xia, Tieshan Zhang, Lei Xia, Wei Wang, Cunbo Jia, Guangliang Shan, Zhenguo Zhai, Chen Wang, Chinese Prevention Strategy for Venous Thromboembolism (CHIPS-VTE) study group
- A care pathway for the cardiovascular complications of COVID-19: Insights from an institutional response
- Rahul S. Loungani, Michael R. Rehorn, L. Kristin Newby, Jason N. Katz, Igor Klem, Robert J. Mentz, W. Schuyler Jones, Sreekanth Vemulapalli, Anita M. Kelsey, Michael A. Blazing, Jonathan P. Piccini, Manesh R. Patel
Bienvenue sur EM-consulte, la référence des professionnels de santé.
L’accès au texte intégral de cet article nécessite un abonnement.
Déjà abonné à cette revue ?