Clinical Trial

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

Study acronym: PIV-EPIC
Recruiting
View on ClinicalTrials.gov →
Summary
This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with the latest generation drug-coated balloon (DCB). The study includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2024-07-30; most recent amendment 2026-01-21.
Status change: Not Yet Recruiting → Recruiting 2026-01-21
Trial Details
NCT Number NCT06535568
Lead Sponsor Fondazione Ricerca e Innovazione Cardiovascolare ETS
Collaborators: Fundación EPIC
Conditions Coronary Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia, Atherosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Coronary Artery Disease +17 more
Enrollment 576 participants
Start Date 2026-01-10
Primary Completion 2028-01-20 (estimated)
Study Completion 2028-02-20 (estimated)
Updated on ClinicalTrials.gov 2026-01-22