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

ConditionsCoronary Disease Heart Diseases Cardiovascular Diseases Myocardial Ischemia Atherosclerosis Arterial Occlusive Diseases Vascular Diseases Coronary Artery Disease Acute Coronary Syndrome Coronary Stenosis Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors MTOR Inhibitors Protein Kinase Inhibitors Physiological Effects of Drugs Immunosuppressive Agents Antineoplastic Agents High Bleeding Risk Single Antiplatelet Therapy Dual Antiplatelet Therapy Cyclooxygenase Inhibitors P2Y12 Inhibitor Platelet Aggregation Inhibitors Aspirin Clopidogrel

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

AgeNot listed

SponsorFondazione Ricerca e Innovazione Cardiovascolare ETS

About this trial

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.

Eligibility criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

Drug-coated balloon
Single antiplatelet therapy (SAPT)
Dual antiplatelet therapy (DAPT)

Treatment groups

576 Participants

are divided into 2 treatment groups

Locations

IRCCS Auxologico Milano20149, MilanMI, Italy

Sponsors and collaborators

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Lead sponsor

Fundación EPIC

Collaborator

Source ClinicalTrials.gov