Trial to show the impact of nicorandil in angina (IONA): design, methodology, and management

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Abstract
OBJECTIVE IONA (impact of nicorandil in angina) is a randomised, double blind, placebo controlled trial that will test the hypothesis that nicorandil (target dose of 20 mg twice daily) will reduce the incidence of cardiovascular events in a cohort of men and women with effort angina and additional risk factors. METHODS The primary composite end point of the study is coronary heart disease death, non-fatal myocardial infarction or unplanned hospital admission for cardiac chest pain, and the secondary end point is the combined outcome of coronary heart disease death or non-fatal myocardial infarction. Other cardiovascular outcomes and all cause mortality will also be reported. RESULTS More than 5000 subjects have been randomised to receive nicorandil or placebo in addition to normal antianginal treatment. The target population, the assessments made, and the management of the trial are described in detail. CONCLUSIONS The IONA study has achieved its first aim of randomising more than 5000 high risk subjects with effort angina. Subject follow up will be complete in the third quarter of 2001.