NCT06535568

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

International, Multicenter, Investigator-driven Randomized Clinical Trial to Assess the Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (PICCOLETO IV-EPIC 38)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 576 (estimated)
• Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of the PICCOLETO IV-EPIC 38 study is to observe and evaluate the efficacy and safety of single antiplatelet therapy (SAPT) after successful PCI with the Essential Pro drug-coated balloon in native coronary artery disease in vessels with a diameter between 2.0 and 4.0 mm, compared to routine dual antiplatelet therapy (DAPT). Patients aged 75 years or older, or those at high bleeding risk, with stable or unstable coronary syndromes will be enrolled and randomized in this study.

Conditions

• Coronary Disease
• Heart Diseases
• Cardiovascular Diseases
• Myocardial Ischemia
• Atherosclerosis
• Arterial Occlusive Diseases
• Vascular Diseases
• Coronary Artery Disease
• Acute Coronary Syndrome
• Coronary Stenosis
• Molecular Mechanisms of Pharmacological Action
• Enzyme Inhibitors
• MTOR Inhibitors
• Protein Kinase Inhibitors
• Physiological Effects of Drugs
• Immunosuppressive Agents
• Antineoplastic Agents
• High Bleeding Risk
• Single Antiplatelet Therapy
• Dual Antiplatelet Therapy
• Cyclooxygenase Inhibitors
• P2Y12 Inhibitor
• Platelet Aggregation Inhibitors
• Aspirin
• Clopidogrel

Interventions

Type	Name	Description
DEVICE	Drug-coated balloon	Essential Pro paclitaxel eluting coronary balloon dilatation catheter is a rapid exchange catheter, also known as RX because it has a proximal simple lumen configuration and a distal coaxial dual lumen, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this Arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.
DRUG	Single antiplatelet therapy (SAPT)	The antithrombotic regimen is single antiplatelet therapy (SAPT). The Investigator will decide if to use aspirin or clopidogrel, whereas ticagrelor or prasugrel are not recommended in our study population since no benefit (or even harm) has been shown by these drugs in head-to-head trials versus clopidogrel in elderly PCI populations. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.
DRUG	Dual antiplatelet therapy (DAPT)	The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.

Timeline

• Start date: 2026-01-10
• Primary completion: 2028-01-20
• Completion: 2028-02-20
• First posted: 2024-08-02
• Last updated: 2026-01-22

Locations

1 site across 1 country: Italy