Actively Recruiting
International, Multicenter, Investigator-driven Randomized Clinical Trial to Assess Single vs. Dual Antiplatelet Therapy in Elderly or High Bleeding Risk Patients Undergoing Percutaneous Intervention with Drug-coated Balloons (PICCOLETO IV-EPIC 38)
Led by Fondazione Ricerca e Innovazione Cardiovascolare ETS · Updated on 2026-01-22
576
Participants Needed
1
Research Sites
4 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
Researchers are evaluating the safety and effectiveness of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) using the latest drug-coated balloon (DCB). This international, multicenter, open-label randomized trial includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events in this population. Participants will receive PCI treatment with the Essential Pro drug-coated balloon in coronary arteries of 2.0 to 4.0 mm diameter. After successful PCI, patients will be randomly assigned to either single antiplatelet therapy, where the investigator chooses aspirin or clopidogrel, or to dual antiplatelet therapy based on local standards and guidelines. The study will follow patients to compare outcomes of these two antiplatelet regimens. During the study, participants will be monitored for net adverse clinical events (NACE) over 12 months, including bleeding events categorized by a standardized bleeding scale and procedural success immediately after PCI. Researchers will collect data on patient-centered composite outcomes and safety measures. The total participation duration includes 12 months of follow-up to observe treatment effects and adverse events.
CONDITIONS
Brief Title
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
Who Can Participate
Eligibility Criteria
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 PCI 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
- Informed consent given by the patient or impartial witness
You will not qualify if you...
- Stent implantation during the index or recent (less than 6 months) procedure
- Known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel, contrast media, or related excipients that cannot be pre-medicated
- Pregnancy at the time of hospitalization
- Participation in another clinical study with investigational drug or device within 30 days or 5 half-lives of study drug
- ST-elevation myocardial infarction
- Life expectancy less than 12 months
- Left ventricular ejection fraction less than 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 bypass graft
- History of asthma caused by salicylates or similar substances
- History of gastrointestinal bleeding or ulcer related to NSAIDs or anticoagulants, or intracranial hemorrhage
- Acute gastrointestinal ulcers
- Known bleeding disorders or ongoing active bleeding
- Severe renal impairment (eGFR less than 30 mL/min)
- Severe hepatic impairment with elevated liver enzymes or bilirubin
- Severe heart failure (NYHA class III or IV)
- Methotrexate use at doses of 15 mg/week or more
- Baseline neutrophil count less than 1500 cells/mm3
- Breastfeeding women
- Full-blown thyrotoxicosis
- Very high risk of thrombosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of the procedure
Participants undergo percutaneous coronary intervention (PCI) with the Essential Pro drug-coated balloon as part of their treatment.
1 visit (in-person)
Duration - Up to 12 months
Participants receive either single antiplatelet therapy (SAPT) or dual antiplatelet therapy (DAPT) following PCI, with treatment duration selected based on clinical characteristics.
Regular visits as determined by clinical care
Duration - Up to 12 months post-treatment
Participants are monitored for safety and efficacy outcomes including bleeding events and clinical endpoints up to 12 months after treatment.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
IRCCS Auxologico Milano
Milan, MI, Italy, 20149
Actively Recruiting
Research Team
B
Bernardo Cortese, MD MSc
B
Beatrice Barbano
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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