INCLINE Clinical Trial
The ROXI-INCLINE study is a phase 3 clinical trial designed to evaluate new potential treatments for individuals with Atrial Fibrillation (AF) who are at risk for stroke but for whom standard anticoagulant therapy is unsuitable. This research aims to find safer and more effective ways to protect veterans and the wider community from stroke.
Purpose of the Study
Many patients with Atrial Fibrillation face a difficult challenge: the same factors that increase their risk of stroke, such as advanced age or renal dysfunction, also increase their risk of bleeding with standard oral anticoagulation (OAC) therapies. This concern often leads to patients not receiving anticoagulant therapy, or receiving doses that are too low to be effective. It is estimated that 40% to 50% of eligible patients with AF do not receive adequate treatment, leaving them vulnerable to stroke.
The INCLINE study will assess the efficacy and safety of two investigational medications, REGN7508 and REGN9933, compared to a placebo. The goal is to determine if these treatments can reduce the risk of stroke and systemic embolism in this high-risk population without increasing the risk of bleeding.