Designing clinical trials for paroxysmal atrial tachycardia and other paroxysmal arrhythmias.
Paroxysmal atrial tachycardia may be useful as a model for designing clinical trials of paroxysmal tachycardia. Individual occurrences of paroxysmal atrial tachycardia are clinically independent events, and the time periods between events follow an exponential probability distribution; i.e. paroxysmal atrial tachycardia behaves like a Poisson process. We propose that treatment of paroxysmal atrial tachycardia can be studied efficiently using a clinical trial with a two period cross-over design in which placebo and investigational therapy are delivered in random order. A screening phase, dose ranging phase, and both limbs of a cross-over plane can be completed in 180 days or less in each patient.
Pritchett
E L
EL
Department of Medicine, Duke University Medical Center, Durham, North Carolina 27710.
Lee
K L
KL
D000889:Anti-Arrhythmia Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000379:methods*; D004311:Double-Blind Method; D004562:Electrocardiography; D006801:Humans; D011897:Random Allocation; D012107:Research Design; D013614:Tachycardia, Paroxysmal / Q000188:drug therapy*; D013617:Tachycardia, Supraventricular / Q000188:drug therapy*
D000889:Anti-Arrhythmia Agents