drugset / Trial / NCT06535568
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
Recruiting
576 enrolled
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Fundación EPIC · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | — | — |
| Subject | Clopidogrel | Small molecule | — | — |