Statistical Analysis Plan: Clarithromycin and the Risk of incident Atrial Fibrillation -a secondary analysis of the CLARICOR (clarithromycin for patients with stable coronary heart disease) trial
Creators
- 1. The Copenhagen City Heart Study, Frederiksberg Hospital and University of Southern Denmark.
- 2. Copenhagen Trial Unit, Centre for Clinical Intervention Research, Copenhagen University Hospital - Rigshospitalet, Copenhagen, Denmark.
- 3. Department of Cardiology, Copenhagen University Hospital Amager Hvidovre, Denmark
- 4. Section of Biostatistics, Department of Public Health, University of Copenhagen, Copenhagen, Denmark
Description
Introduction
Atrial fibrillation (AF) is the most common cardiac arrhythmia, and AF is a major contributor to cardiovascular mortality and morbidity. The CLARICOR randomised trial of clarithromycin compared with placebo in patients with stable coronary heart disease trial, found increased all-cause and cardiovascular mortality of the brief clarithromycin regimen. Here, we outline an analysis of the relationship between use of clarithromycin and incident AF in the CLARICOR trial.
Methods
The CLARICOR trial randomised 4372 patients with stable coronary artery disease in Copenhagen during October 1999 to April 2000. Outcomes were assessed through validated Danish registers. The outcome of interest is incident AF assessed through Danish national registers. Using Cox proportional hazard method, we will determine the effect of clarithromycin on incidence of AF. The analyses will be adjusted for protocol specified stratification variables. Analyses both including and excluding participants with AF occurring before randomisation will be performed.
Conclusion
This study will potentially contribute to the understanding of development of AF, relative to use of clarithromycin in such patients.
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