ACTION - A 30000 PATIENT-YEARS DOUBLE-BLIND, PLACEBO-CONTROLLED TRIALOF NIFEDIPINE GITS IN STABLE ANGINA

To assess the overall balance between efficacy and safety of the long- acting calcium antagonist nifedipine gastrointestinal therapeutic syst em (GITS) in patients with stable symptomatic coronary artery disease (CAD), a large multicentre placebo-controlled double-blind trial calle d ACTION has been mounted (A Coronary Disease Trial Investigating Outc ome with Nifedipine GITS). Patients are eligible if they have proven C AD on antianginal treatment in stable clinical condition for at least 3 months without heart failure. The left ventricular ejection fraction must be above 40%. Patients not already on lipid-lowering therapy wil l be evaluated and such treatment will be started based on current gui delines before randomisation. After washout of an already given calciu m antagonist, more than 6000 patients in total will be randomised in e qual proportions to either nifedipine GITS 60 mg once daily or placebo . The mean clinical follow-up will be 5 years, with no restrictions on concomitant medication (with the exception of digitalis, calcium anta gonists and class III antiarrhythmics). The primary end-point will be survival free of major cardiovascular events tie survival free of acut e myocardial infarction, emergency coronary angiography, overt heart f ailure, stroke and peripheral revascularisation). The study has 95% po wer to detect a significant (p < 0.05) 18% improvement of this end-poi nt and is of sufficient size to exclude an excess mortality of 3.1 per 1000 patient-years. In this first stable angina trial of this size an d scope, 185 centres in Canada, Europe, Israel, Australia and New Zeal and will participate. Recruitment will start in November 1996 and is p lanned to be completed in 2 years.