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

Recruiting N/A Interventional Study
Coronary 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
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
576 (estimated)
Sponsor
Fondazione Ricerca e Innovazione Cardiovascolare ETS · Other
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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 syn…
Trial Locations
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Eligibility Criteria
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 vess…
Contacts

Bernardo Cortese, MD MSc

216-296-9747

bcortese@gmail.com

CONTACT

Beatrice Barbano

segreteria@fondazioneric.org

CONTACT