drugset / Trial / NCT06535568

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

NCT06535568

RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-01-10
Primary completion
2028-01-20
Completion
2028-02-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule
Subject Clopidogrel Small molecule