Bayer and Ortho-McNeil, Inc. Outline Phase III Study Program of Oral Factor Xa Inhibitor Rivaroxaban in Chronic Indications
Patient Recruitment for Phase III Clinical Trial to Start in Studies of Oral Anticoagulant in Chronic Indications
After extensive discussions with the regulatory authorities in the U.S. and Europe, Bayer and Ortho-McNeil, Inc. have determined the final design of the phase III study program for the oral anticoagulant rivaroxaban in two chronic indications: stroke prevention in atrial fibrillation (SPAF) and treatment and long-term secondary prevention of venous thromboembolism (VTE).
Stroke prevention in atrial fibrillation represents the largest potential indication. The phase III program consists of one large, double-blind trial, which is designed to demonstrate non-inferiority of rivaroxaban against the current standard treatment of dose-adjusted warfarin. The principle investigator will be Robert Califf, M.D., director of the Duke Clinical Research Institute at the Duke University Medical Center, in Durham, North Carolina. The trial will include an estimated 14,000 patients, across 1,100 centres in more than 40 countries. This will be an event-driven study, meaning it will depend upon the occurrence of a statistically required number of strokes or systemic embolisms. After extensive dose-finding studies, the standard dose for rivaroxaban has been set at 20 mg once daily.
The VTE treatment program consists of two open label trials in patients with deep vein thromboembolism (DVT) and pulmonary embolism (PE) with a variable length of treatment up to 12 months against current standard treatment of low molecular weight heparin followed by dose-adjusted Vitamin-K antagonist. A third double-blind, placebo-controlled trial will analyze the value of prolonged treatment in this indication. The principle investigator for these trials is Harry Bueller, M.D., PhD, of the Academic Medical Center in Amsterdam. These event-driven studies will recruit about 7,500 patients, in about 300 centers in more than 20 countries. The study will use oral rivaroxaban for both the initial, intensified treatment phase as well as for the following period. The main dose of rivaroxaban will be 20mg once daily.
Rivaroxaban is an oral, direct Factor Xa inhibitor that could potentially reduce the risk of life-threatening thromboembolic events. Factor Xa, the target enzyme, is a protease that acts to hinder blood clotting at the pivotal point in the coagulation cascade, the process that leads to clot formation. Published results show that rivaroxaban offers predictable anticoagulation across a wide range of parameters, which strongly suggests that routine coagulation monitoring will not be required. In addition, data also show that rivaroxaban does not interact with a wide variety of drugs that are commonly given concomitantly with an anticoagulant.
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