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

NCT06535568 | Recruiting DMC

• 1 other identifier: PICCOLETO IV-EPIC 38
• Study Type: interventional
• Target: 576
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Atherosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Artery Disease; Acute Coronary Syndrome; Coronary Stenosis; Enzyme Inhibitors; MTOR 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; Protein Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action

Keywords

DCB; Angioplasty; Paclitaxel; Antiplatelet treatment; Single antiplatelet therapy (SAPT); Dual antiplatelet therapy (DAPT); High bleeding risk (HBR); MACE; Native CAD; stable or unstable coronary syndromes

Outcome Measures

Primary Outcomes (1)

• Rate of Net Adverse Clinical Events (NACE) at 12 months

  Superiority of single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with drug-coated balloons (DCB), assessed by the rate of Net Adverse Clinical Events (NACE). NACE is defined as the composite of major adverse cardiovascular events (MACE) plus clinically relevant bleeding events classified as BARC 2, 3, or 5, evaluated at 12 months following successful PCI with DCB.

  12 months

Secondary Outcomes (3)

• Rate of Clinically Relevant Bleeding Events (Bleeding Academic Research Consortium [BARC] Scale, Grades 2-5; range 0-5, where higher grades indicate more severe bleeding and worse clinical outcome)

  12 months

• Procedural success rate immediately post-PCI

  Post-PCI

• Patient-oriented composite endpoint (PoCE)

  12 months

Study Arms (2)

Single antiplatelet therapy

EXPERIMENTAL

Device: Drug-coated balloon; Drug: Single antiplatelet therapy (SAPT)

Dual antiplatelet therapy

ACTIVE COMPARATOR

Device: Drug-coated balloon; Drug: Dual antiplatelet therapy (DAPT)

Interventions

Single antiplatelet therapy (SAPT) DRUG

The antithrombotic regimen is single antiplatelet therapy (SAPT). The Investigator will decide if to use aspirin or clopidogrel, whereas ticagrelor or prasugrel are not recommended in our study population since no benefit (or even harm) has been shown by these drugs in head-to-head trials versus clopidogrel in elderly PCI populations. The type of agent and treatment duration will be selected according to the clinical characteristics of the patient.

Single antiplatelet therapy

Dual antiplatelet therapy (DAPT) DRUG

The antithrombotic regimen will follow the standard of care with a dual antiplatelet regimen (DAPT) per local preferences and international guidelines/ARC consensus paper. The type of agent and treatment duration will be selected according to the patient's clinical characteristics.

Dual antiplatelet therapy

Drug-coated balloon DEVICE

Essential Pro paclitaxel eluting coronary balloon dilatation catheter is a rapid exchange catheter, also known as RX because it has a proximal simple lumen configuration and a distal coaxial dual lumen, intended for coronary arteries percutaneous transluminal angioplasties. Patients assigned to this Arm will be treated with a Drug-Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care.

Dual antiplatelet therapy; Single antiplatelet therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• Fundación EPIC: collaborator
• Fondazione Ricerca e Innovazione Cardiovascolare ETS: lead

Study Sites (1)

IRCCS Auxologico Milano

Milan, MI, 20149, Italy

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Atherosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Coronary Artery Disease; Acute Coronary Syndrome; Coronary Stenosis

Condition Hierarchy (Ancestors)

Arteriosclerosis

Central Study Contacts

Bernardo Cortese, MD MSc

CONTACT

216-296-9747; bcortese@gmail.com

Beatrice Barbano

CONTACT

segreteria@fondazioneric.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2024
• First Posted: August 2, 2024
• Study Start: January 10, 2026
• Primary Completion (Estimated): January 20, 2028
• Study Completion (Estimated): February 20, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

IT (1)