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Janssen has announced results from its Phase 3b exploratory trial evaluating the efficacy of Xarelto (rivaroxaban) as an alternative to vitamin K antagonists (VKAs) for treating and reducing the risk of blood clots in non-valvular atrial fibrillation (NVAF) in patients undergoing elective cardioversion.
X-VeRT (eXplore the efficacy and safety of once-daily oral riVaroxaban for the prEvention of caRdiovascular events in patients with nonvalvular aTrial fibrillation scheduled for cardioversion) was a prospective, randomized, open-label, parallel group study of 1,504 patients from 16 countries with hemodynamically stable NVAF of >48 hours or unknown duration. Patients were randomized to rivaroxaban 20mg once-daily (15mg if CrCl 30–49mL/min) or INR-adjusted VKA therapy in a 2:1 ratio.
Regarding the primary efficacy outcome of stroke, transient ischemic attack, peripheral embolism, myocardial infarction, and cardiovascular-related mortality, 0.51% of patients taking rivaroxaban experienced this vs. 1.02% of patients treated with VKA. For patients taking rivaroxaban, 0.61% experienced a major bleeding event compared to 0.81% treated with VKA. However, the differences in efficacy and safety primary endpoints were not statistically significant based on the design of this trial.
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This study is part of the larger EXPLORER research program that includes 11 trials assessing the safety and efficacy of rivaroxaban in high-risk patient populations, including those with chronic heart failure, coronary artery disease, peripheral artery disease, acute coronary syndrome, and embolic stroke of undetermined source. X-VeRT is the first prospective study of any Factor Xa inhibitor in this high-risk patient population.
Xarelto is an oral Factor Xa inhibitor currently approved to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery, to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by heart valve problem, to treat people with pulmonary embolism (PE) or deep vein thrombosis (DVT), and to reduce the risk or recurrence of DVT or PE following an initial 6 months of treatment for acute venous thromboembolism.
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