PICCOLETO IV EPIC 38

Study Chairman: Prof. Bernardo Cortese, Dr Armando Perez del Prado
Steering Committee: Dr Manel Sabatè, Dr Chema de la Torre, Prof Stefano de Servi
DSMB Coordinator: Prof Davide Capodanno

PICCOLETO IV-EPIC 38 is an investigator-driven international randomized clinical trial and is designed to test the hypothesis that a single antiplatelet treatment (SAPT) is not inferior to dual antiplatelet therapy (DAPT) in patients at HBR or >75 y.o. who have undergone paclitaxel drug-coated balloon (DCB) angioplasty. The study will compare the effectiveness and safety of these two antiplatelet regimens in order to determine the best course of action for this frail patient population. The results of this trial have the potential to significantly impact and improve the treatment of patients who have undergone DCB angioplasty, particularly those with a high risk of bleeding. This trial, led by Fondazione RIC, is run in collaboration with Fundacion EPIC in Spain and will enroll patients in Spain, Italy, Belgium and Luxemburg. We obtained the final regulatory approvals, and the first site initiation visits and enrollments began in Q1.

The first patient was enrolled by Dr. Davide Sala from Istituto Auxologico Italiano – Ospedale San Luca in March 2026.

The study manuscript titled “Single vs. dual antiplatelet therapy in elderly or HBR patients undergoing percutaneous interventions with drug-coated balloons: Design and Rationale of PICCOLETO IV-EPIC 38 study” has been accepted for publication in the American Heart Journal.

Enrolment began in Q1 and is currently ongoing.

Are you interested in participating in the study?

THE STUDY SITES AND CENTERS