Coronary DiseasePIV-EPICNCT06535568

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

A study testing Drug-coated balloon, Single antiplatelet therapy (SAPT) and Dual antiplatelet therapy (DAPT) in people with Coronary Disease and Heart Diseases, run by Fondazione Ricerca e Innovazione Cardiovascolare ETS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Any age
Conditions the study is for: Coronary Disease, Heart Diseases, Cardiovascular Diseases
What is being tested?: Drug-coated balloon, Single antiplatelet therapy (SAPT) and Dual antiplatelet therapy (DAPT)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 576 participants
Where: 1 siteItaly
Study dates: 10 Jan 2026to 20 Feb 2028
Phase: Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bernardo Cortese, MD MSc contact

216-296-9747

bcortese@gmail.com

Beatrice Barbano contact

segreteria@fondazioneric.org

Italy1 site, 1 recruiting

IRCCS Auxologico Milano
Milan, MI, 20149
Davide Dr Sala
Recruiting

Other trials in Italy

About this study

Official title: 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)

Read the 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
Being tested: Drug-coated balloon, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT)
Keywords: DCB, Angioplasty, Paclitaxel, Antiplatelet treatment, Single antiplatelet therapy (SAPT), Dual antiplatelet therapy (DAPT), High bleeding risk (HBR), MACE, Native CAD, stable or unstable coronary syndromes
Medical subject headings: Coronary Disease, Heart Diseases, Cardiovascular Diseases, Myocardial Ischemia, Atherosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Drug-coated balloonDevice
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)Drug
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)Drug
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 groups in NCT06535568
Study group	Role	What they receive
Single antiplatelet therapy	Experimental	Not described Receives: Device: Drug-coated balloon; Drug: Single antiplatelet therapy (SAPT)
Dual antiplatelet therapy	Active comparator	Not described Receives: Device: Drug-coated balloon; Drug: Dual antiplatelet therapy (DAPT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of Net Adverse Clinical Events (NACE) at 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.
Measured: 12 months

Secondary outcomes (3)

Rate of Clinically Relevant Bleeding Events (Bleeding Academic Research Consortium [BARC] Scale, Grades 2-5; range 0-5, where higher grades indicate more severe bleeding and worse clinical outcome)
Incidence of clinically relevant bleeding events classified as BARC grades 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) bleeding definition (scale range 0-5; higher scores indicate worse outcome) in elderly or high bleeding risk patients treated with single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) with drug-coated balloon (DCB).
Measured: 12 months
Procedural success rate immediately post-PCI
Defined as final stenosis <30%, distal TIMI 3 flow, and no major in-hospital adverse events.
Measured: Post-PCI
Patient-oriented composite endpoint (PoCE)
Composite of all-cause death, all myocardial infarctions (MIs), or any repeat revascularization.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202620 Feb 2028

First posted2 Aug 2024
Study start10 Jan 2026
Primary completion20 Jan 2028 (estimated)
Study completion20 Feb 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 576 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06535568
Sponsor's protocol ID: PICCOLETO IV-EPIC 38
Acronym: PIV-EPIC
Status last verified: Jan 2026
First submitted: 30 Jul 2024
Last updated: 22 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Bernardo Cortese, MD MSc

216-296-9747

bcortese@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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