December 29, 2010 – Patient enrollment has been completed for a Phase III trial of an oral Factor Xa inhibitor. The ENGAGE AF-TIMI 48 study will investigate edoxaban, by Daiichi Sankyo, for preventing strokes and systemic embolic events (SEE) in patients with atrial fibrillation (AF).
Edoxaban is a once-daily oral anticoagulant that directly inhibits Factor Xa, an important factor in the coagulation process. The drug could be a potential new treatment for preventing both arterial and venous thromboembolism.
The study began enrollment in November 2008. It is an event-driven, randomized, double-blind, double-dummy, parallel group, multi-center, multi-national study designed to assess the efficacy and safety of edoxaban compared to the current standard of care, warfarin. Patients in the study are randomized to one of three treatment groups: 30 mg edoxaban once daily, 60 mg edoxaban once daily, or warfarin, a vitamin K antagonist. In addition, edoxaban doses are further adjusted to treat patients with renal impairment and/or low body weight, or those taking strong P-glycoprotein inhibitors. Those randomized to warfarin are dosed once daily to achieve an International Normalized Ratio (INR) between 2.0 and 3.0.
This Phase III global AF study enrolled 21,107 subjects at nearly 1,400 clinical trial sites located throughout North America, South America, Africa, Asia, Europe and Australia/New Zealand. The primary endpoint of this study is to compare the efficacy of edoxaban to warfarin in the prevention of stroke and SEE. The primary safety assessment is the incidence of major bleeding events.
“As new options to prevent stroke in AF patients become available, it will be important that these treatments eliminate the need for extensive monitoring and dietary modifications,” said Elliott Antman, M.D., professor of medicine, Harvard Medical School, senior investigator with the Brigham and Women's Hospital-based TIMI Study Group. “Based on Phase II study results, edoxaban has shown promise of potentially addressing the needs of patients with AF and the physicians caring for them.”
For more information: www.daiichisankyo.com