Single Versus Dual Antiplatelet Medicine After Heart Stent Balloon Treatment

Trial details

Who runs it

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Trial code

NCT06535568

Record updated

22 January 2026

Original description

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.Read full original descriptionShow less

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)

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.

Inclusion: 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: 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; History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage; 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; ST-elevation myocardial infarction; History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs); Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding); Severe cardiac failure (NYHA grade III or IV); Patients with a very high risk of thrombosis; Left ventricular ejection fraction <30%; 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); Patients with baseline neutrophil counts < 1500 cells/mm³; Stent implantation during index or recent (<6 months) procedure; Pregnancy at the time of hospitalization; Life expectancy <12 months; 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; Acute gastrointestinal ulcers; Combination with methotrexate at doses of 15 mg/week or more; Breastfeeding women; Full-blown thyrotoxicosis.

ClinicalTrials.gov NCT06535568