Actively Recruiting

Phase Not Applicable
All Genders
NCT06535568

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

Led by Fondazione Ricerca e Innovazione Cardiovascolare ETS · Updated on 2026-01-22

576

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

Sponsors

F

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Lead Sponsor

F

Fundación EPIC

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male and female patients aged 75 years or older, or aged 18 years or older with high bleeding risk
  • Successful percutaneous coronary intervention with Essential Pro drug-coated balloon in 1 to 3 coronary vessels
  • Stable or unstable coronary syndromes
  • De novo coronary lesions in vessels with diameter between 2.0 and 4.0 mm (visual estimation)
  • Provided informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Stent implantation during the current or recent procedure within the past 6 months
  • Known, untreatable hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, contrast media, or related excipients
  • Pregnancy at the time of hospitalization
  • Participation in another clinical study involving investigational drugs or devices within 30 days or within 5 half-lives of the study drug
  • ST-elevation myocardial infarction
  • Life expectancy less than 12 months
  • Left ventricular ejection fraction below 30%
  • Visible thrombus at lesion site
  • Target lesion or vessel with severe or extensive calcification, left main stem stenosis over 50%, lesion in left main stem, chronic total occlusion requiring retrograde approach, or lesion in a bypass graft
  • History of asthma induced by salicylates or NSAIDs
  • History of gastrointestinal perforation, ulceration, bleeding related to NSAIDs or anticoagulants, or intracranial hemorrhage
  • Acute gastrointestinal ulcers
  • Hemorrhagic diathesis, including known bleeding disorders or active bleeding
  • Severe renal impairment (eGFR below 30 mL/min)
  • Severe hepatic impairment (Child-Pugh C) with elevated liver enzymes or bilirubin
  • Severe cardiac failure (NYHA grade III or IV)
  • Use of methotrexate at doses 15 mg/week or more
  • Baseline neutrophil counts below 1500 cells/mm³
  • Breastfeeding women
  • Full-blown thyrotoxicosis
  • Patients with very high risk of thrombosis

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Auxologico Milano

Milan, MI, Italy, 20149

Actively Recruiting

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Research Team

B

Bernardo Cortese, MD MSc

CONTACT

B

Beatrice Barbano

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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