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

NCT06535568 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Phase

Not applicable

Started

2026-01-10

Last updated

2026-01-22

Condition(s) studied

Coronary DiseaseHeart DiseasesCardiovascular DiseasesMyocardial IschemiaAtherosclerosisArterial Occlusive DiseasesVascular DiseasesCoronary Artery DiseaseAcute Coronary SyndromeCoronary StenosisMolecular Mechanisms of Pharmacological ActionEnzyme InhibitorsMTOR InhibitorsProtein Kinase InhibitorsPhysiological Effects of DrugsImmunosuppressive AgentsAntineoplastic AgentsHigh Bleeding RiskSingle Antiplatelet TherapyDual Antiplatelet TherapyCyclooxygenase InhibitorsP2Y12 InhibitorPlatelet Aggregation InhibitorsAspirinClopidogrel

Investigational drug(s) / intervention(s)

Drug-coated balloonSingle antiplatelet therapy (SAPT)Dual antiplatelet therapy (DAPT) →

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.

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.

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.

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

Inclusion Criteria: Male and female patients who meet the following criteria: * Age ≥ 75 years or age ≥ 18 years at high bleeding risk; * Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels; * Stable or unstable coronary syndromes; * De novo coronary lesions in vessels with diameter ≥2.0 and ≤4.0 mm (visual estimation); * Informed consent to participate in the study given by the patient or impartial witness. Exclusion Criteria: * Stent implantation during index or recent (\<6 months) procedure; * Known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel or contrast media, or any of their excipient which cannot be adequately pre-medicated; * Pregnancy at the time of hospitalization; * Patients participating in another clinical study in which an investigational drug or device was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer; * ST-elevation myocardial infarction; * Life expectancy \<12 months; * Left ventricular ejection fraction \<30%; * Visible thrombus at lesion site; * Target lesion/vessel with any of the following characteristics: * severe and/or \>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging not mandatory); * left main stem stenosis \>50%; * target lesion is in the left main stem; * chronic total occlusion with anticipated necessity of retrograde approach; * lesion is in a bypass graft. * History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs); * History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage; * Acute gastrointestinal ulcers; * Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding); * Severe renal impairment (eGFR \< 30 mL/min); * Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT/AST \> 2 x ULN or total bilirubin \>1.5 x ULN); * Severe cardiac failure (NYHA grade III or IV); * Combination with methotrexate at doses of 15 mg/week or more; * Patients with baseline neutrophil counts \< 1500 cells/mm³; * Breastfeeding women; * Full-blown thyrotoxicosis; * Patients with a very high risk of thrombosis.

Primary outcome measure(s)

Rate of Net Adverse Clinical Events (NACE) at 12 months — 12 months
Superiority of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB), assessed by the rate of Net Adverse Clinical Events (NACE). NACE is defined as the composite of major adverse cardiovascular events (MACE) plus clinically relevant bleeding events classified as BARC 2, 3, or 5, evaluated at 12 months following successful PCI with DCB.

Trial sites (1)

Facility	City	Region	Status
IRCCS Auxologico Milano	Milan	MI	Recruiting

More Fondazione Ricerca e Innovazione Cardiovascolare ETS trials in Italy

Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels - TRANSFORM II Active, not recruiting

DCB vs. DES in Bifurcation Coronary Lesions Recruiting

Other trials for the same condition

New Technological Pathway for Gait Rehabilitation Starting soon

AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices Recruiting

Feasibility of a Deep Learning-based Algorithm for Non-invasive Assessment of Vulnerable Coronary Plaque Starting soon

Trustworthy, Integrated Artificial Intelligence Tools for Predicting High-risk CORonary PlaqueS Recruiting

EASi-PROTKT™ - A Study to Test Vicadrostat (BI 690517) Taken Together With Empagliflozin in People With Type 2 Diabetes, High Blood Pressure, and Cardiovascular Disease Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06535568 on ClinicalTrials.gov ↗ ← All trials in Italy