ALLiance for SEcondary PREvention After an Episode of Acute Coronary Syndrome. the ALLEPRE Trial: a Fully Nurse-led Intensive Intervention Programme

ALLEPRE enrols a population of residents in Emilia Romagna with a diagnosis of ACS (unstable angina, non-ST segment elevation myocardial infarction, ST segment elevation myocardial infarction) who were admitted to the specialist cardiological departments of the participating centres up to 20 days after the index event.

All eligible patients are randomised 1:1 to the nurse-led intensive secondary prevention programme (ISPP: intervention/experimental arm) or usual treatment (UT: control arm).

Randomisation is centralised by means of IVRS under the responsibility of the Study Coordinator and the Principal Investigator at each hospital centre, and the patients are the allocated to groups by e-mail. Due to the nature of the study, neither participants nor research personnel can be blinded to the group assignments. The randomisation data are kept at the coordinating centre.

OPERATIVE PHASE After randomisation, all of the patients in both arms undergo a baseline examination and are required to return to their reference centre for follow-up visits after 12, 24 and 60 months for outcome assesment. Outcomes will also be recorded after 36 and 48 months on the basis of telephone enquiries.

ISPP: intervention arm. This consists of a series of programmed sessions involving the centrally trained nurses and the patients randomised to the ISPP. There will be a total of nine sessions: before discharge, and one, three, six, 12, 18, 24, 36 and 48 months after discharge. During the sessions, each of which will last for about one hour, the trained nurse will record the main clinical parameters (i.e. risk factors, lifestyle habits, adherence to therapy, and any discrepancies between patient reports and the recommended goals) using an ad hoc clinical file (SIM: scheda infermieristica multidimensionale or multidimensional nursing form), and then activate the interventions laid down by the pre-specified rules inside the SIM in order to correct the discrepancies. The activation of the pre-established multidisciplinary network (anti-smoking, anti-diabetes and anti-hypertension centres, and psychological support) is completely under the nurses' control.