Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervent… (NCT06535568) | Clinical Trial Compass
RecruitingNot Applicable
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)
Italy576 participantsStarted 2026-01-10
Plain-language 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.
Who can participate
SexALL
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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…
What they're measuring
1
Rate of Net Adverse Clinical Events (NACE) at 12 months
Timeframe: 12 months
Trial details
NCT IDNCT06535568
SponsorFondazione Ricerca e Innovazione Cardiovascolare ETS