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

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.

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

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.

Sponsors & Collaborators

• Fundación EPIC

  collaborator OTHER

• Fondazione Ricerca e Innovazione Cardiovascolare ETS

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-10

Primary Completion

2028-01-20

Completion

2028-02-20

Countries

• Italy

Study Locations