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

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Status

Not yet enrolling

Conditions

MTOR Inhibitors

Coronary Artery Disease

Single Antiplatelet Therapy

Physiological Effects of Drugs

Acute Coronary Syndrome

Dual Antiplatelet Therapy

Enzyme Inhibitors

Cardiovascular Diseases

Vascular Diseases

Atherosclerosis

Myocardial Ischemia

Immunosuppressive Agents

Molecular Mechanisms of Pharmacological Action

P2Y12 Inhibitor

Platelet Aggregation Inhibitors

Heart Diseases

Coronary Disease

High Bleeding Risk

Protein Kinase Inhibitors

Antineoplastic Agents

Arterial Occlusive Diseases

Aspirin

Clopidogrel

Coronary Stenosis

Cyclooxygenase Inhibitors

Treatments

Drug: Dual antiplatelet therapy (DAPT)

Drug: Single antiplatelet therapy (SAPT)

Device: Drug-coated balloon

Study type

Interventional

Funder types

Other

Identifiers

NCT06535568

PICCOLETO IV-EPIC 38

Details and patient eligibility

About

International multicenter, investigator-driven, open-label, randomized (1:1) clinical trial to observe and evaluate the rate of ischemic and bleeding adverse events of a single antiplatelet regimen (SAPT) since the time of PCI with latest generation DCB in elderly or HBR population with stable or unstable coronary syndromes.

Full description

The purpose of PICCOLETO IV study is to observe and evaluate the efficacy and safety of a single antiplatelet therapy (SAPT) after successful DCB angioplasty with Essential Pro (Drug-coated balloon (iVascular) in native coronary artery disease in vessels with diameter >=2.0 and <=4.0 mm as compared to the routine dual antiplatelet therapy (DAPT). Patients with stable or unstable coronary syndromes will be enrolled in this study.

Enrollment

416 estimated patients

Sex

All

Ages

75+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

successful PCI with solo-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;
at least one of the following criteria: >=75 y.o.; high bleeding risk (ARC criteria)

Exclusion criteria

stent implantation during index or recent (<6 months) procedure;
patients with known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, contrast media, which cannot be adequately pre-medicated;
patients participating in another clinical study; - pregnancy at the time of hospitalization;
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.