[Multicenter clinical trial on the prevention of sudden death after myocardial infarction by the use of anti-arrhythmia agents. Investigator Group of the Spanish Study on Sudden Death].
We present the study protocol of the Spanish trial on sudden death (STSD) project, to be carried out in collaboration with 24 hospitals (see Annex). The objective of the project is to investigate the effect of antiarrhythmic treatment on the incidence of sudden death of postmyocardial infarction patients with potentially malignant ventricular arrhythmias. A comparison will be made of three patient groups classified according to ejection fraction (EF) and the presence or absence of ventricular arrhythmias. Patients with EF less than 20% and ventricular arrhythmias (group B.1.1) will be randomized into a captopril group and a captopril plus amiodarone group; patients with EF = 20-45% and ventricular arrhythmias (group B.2.1.) will be randomized into amiodarone, metoprolol and placebo groups, and patients with EF greater than 45% (group B.3) will act as controls. Over a projected study period of approximately 3 years we hope to recruit a minimum of 60 patients in the B.1.1. group and 800 patients in the B.2.1. group. Patients and controls will be followed up periodically for 3-4 years. With a series of this size we hope to be able to confirm the effectiveness of treatment with 80-90% accuracy (1-beta) and a level of statistical significance (1-alpha) of 95%.
D000638:Amiodarone / Q000627:therapeutic use*; D001145:Arrhythmias, Cardiac / Q000209:etiology* / Q000517:prevention & control; D002216:Captopril / Q000627:therapeutic use*; D003645:Death, Sudden / Q000209:etiology*; D006801:Humans; D008790:Metoprolol / Q000627:therapeutic use*; D015337:Multicenter Studies as Topic; D009203:Myocardial Infarction / Q000150:complications* / Q000401:mortality; D013030:Spain
D002216:Captopril; D008790:Metoprolol; D000638:Amiodarone
Ensayo clínico multicéntrico sobre la prevención de la muerte súbita con agentes antiarrítmicos en el postinfarto de miocardio. Grupo Investigador del Estudio Español sobre la Muerte Súbita.