Rivaroxaban versus Warfarin in Patients with Mechanical Heart Valve: Rationale and Design of the RIWA Study
| Autor: | Kevan Akrami, Andre Rodrigues Duraes, Edmundo J.N. Camara, Igor S. Schonhofen, Yasmin de Souza Lima Bitar, Jose Admirço Lima Filho, Hugo Eckener Dantas de Pereira Cardoso, Leonardo Roever |
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| Rok vydání: | 2018 |
| Předmět: |
Adult
medicine.medical_specialty Adolescent Heart Valve Diseases Pilot Projects 030204 cardiovascular system & hematology 03 medical and health sciences Young Adult 0302 clinical medicine Pharmacotherapy Clinical Trials Phase II as Topic Rivaroxaban Internal medicine medicine Humans 030212 general & internal medicine Prospective Studies Original Research Article Cardiac Surgical Procedures Prospective cohort study Stroke Aged Randomized Controlled Trials as Topic Pharmacology Clinical Trials Phase I as Topic business.industry Incidence (epidemiology) lcsh:RM1-950 Warfarin Anticoagulants Middle Aged medicine.disease Heart Valves Clinical trial lcsh:Therapeutics. Pharmacology Drug class business Echocardiography Transesophageal medicine.drug |
| Zdroj: | Drugs in R&D Drugs in R&D, Vol 18, Iss 4, Pp 303-308 (2018) |
| ISSN: | 1179-6901 |
| Popis: | Introduction Mechanical heart valves (MHV) are extremely durable, but they require permanent use of anticoagulation to prevent thromboembolic events. The only approved therapeutic options are vitamin K antagonists (VKAs), such as warfarin. As a drug class, clinical management is difficult, therefore new alternatives need to be evaluated. Methods RIWA is a phase II/III, prospective, open-label, randomized, pilot study designed to investigate oral rivaroxaban 15 mg twice daily compared with dose-adjusted warfarin for the prevention of stroke (ischemic or hemorrhagic) and systemic embolism in patients with MHV, from August 2018 to December 2019. Patients will undergo transesophageal echocardiography at the beginning and the end of the study (follow-up time 90 days). On an explanatory basis, all events will be analyzed, including stroke, peripheral systemic embolism, valve thrombosis, significant bleeding and death. Discussion Warfarin and similar VKAs are standard therapy for patients with an MHV. Even with the appropriate use of therapy, the incidence of thromboembolic events is high at 1–4% per year. Furthermore, bleeding risk is significant, ranging from 2 to 9% per year. The new frontier to be overcome in relation to use of the new oral anticoagulants is undoubtedly in patients with MHV. A significant portion of people with MHV worldwide will benefit if noninferiority of these new agents is confirmed. Trial Registration ClinicalTrials.gov identifier: NCT03566303. Recruitment Status: Recruiting. First Posted: 25 June 2018. Last Update Posted: 25 June 2018. |
| Databáze: | OpenAIRE |
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