Status:
NOT_YET_RECRUITING
Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB
Lead Sponsor:
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Collaborating Sponsors:
Fundación EPIC
Conditions:
Coronary Disease
Heart Diseases
Eligibility:
All Genders
75+ years
Phase:
NA
Brief 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 o...
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 (...
Eligibility Criteria
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
- 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 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.
Key Trial Info
Start Date :
January 10 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2027
Estimated Enrollment :
576 Patients enrolled
Trial Details
Trial ID
NCT06535568
Start Date
January 10 2026
End Date
February 20 2027
Last Update
December 30 2025
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