A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Efficacy and Safety of the Oral Soluble Guanylate Cyclase Stimulator
The VICTORIA Trial
Paul W. Armstrong, Lothar Roessig, Mahesh J. Patel, Kevin J. Anstrom, Javed Butler, Adriaan A. Voors, Carolyn S.P. Lam, Piotr Ponikowski, Tracy Temple, Burkert Pieske, Justin Ezekowitz, Adrian F. Hernandez, Joerg Koglin and Christopher M. O'Connor
Approximate VICTORIA trial timelines are shown from first patient enrolled. Key study benchmarks are shown. Note that, given the event-driven nature of the trial, these are estimates. Median treatment duration was planned for ∼480 days. The futility analysis will occur when approximately 50% of the primary events have occurred. The efficacy analysis is planned when 75% of the planned CV death events have occurred. (see Statistical Considerations). CV = cardiovascular; DSMB = Data Safety & Monitoring Board; Q = quarters; VICTORIA = Vericiguat Global Study in Subjects With Heart Failure With Reduced Ejection Fraction.