Designing clinical trials for paroxysmal atrial tachycardia and other paroxysmal arrhythmias

J Clin Epidemiol. 1988;41(9):851-8. doi: 10.1016/0895-4356(88)90101-1.

Abstract

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.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Anti-Arrhythmia Agents / therapeutic use
  • Clinical Trials as Topic / methods*
  • Double-Blind Method
  • Electrocardiography
  • Humans
  • Random Allocation
  • Research Design
  • Tachycardia, Paroxysmal / drug therapy*
  • Tachycardia, Supraventricular / drug therapy*

Substances

  • Anti-Arrhythmia Agents