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

ConditionsCoronary DiseaseHeart DiseasesCardiovascular DiseasesMyocardial IschemiaAtherosclerosisArterial Occlusive DiseasesVascular DiseasesCoronary Artery DiseaseAcute Coronary SyndromeCoronary StenosisMolecular Mechanisms of Pharmacological ActionEnzyme InhibitorsMTOR InhibitorsProtein Kinase InhibitorsPhysiological Effects of DrugsImmunosuppressive AgentsAntineoplastic AgentsHigh Bleeding RiskSingle Antiplatelet TherapyDual Antiplatelet TherapyCyclooxygenase InhibitorsP2Y12 InhibitorPlatelet Aggregation InhibitorsAspirinClopidogrel
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

576 Participants
are divided into 2 treatment groups
Group A: Single antiplatelet therapyExperimental treatment 2 interventions
Group B: Dual antiplatelet therapyActive comparator 2 interventions

Trial outcomes

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.

Time frame
12 months

Secondary outcomes

1

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)

Incidence of clinically relevant bleeding events classified as BARC grades 2, 3, or 5 according to the Bleeding Academic Research Consortium (BARC) bleeding definition (scale range 0-5; higher scores indicate worse outcome) in elderly or high bleeding risk patients treated with single antiplatelet therapy (SAPT) versus dual antiplatelet therapy (DAPT) following percutaneous coronary intervention (PCI) with drug-coated balloon (DCB).

Time frame
12 months
2

Procedural success rate immediately post-PCI

Defined as final stenosis \<30%, distal TIMI 3 flow, and no major in-hospital adverse events.

Time frame
Post-PCI
3

Patient-oriented composite endpoint (PoCE)

Composite of all-cause death, all myocardial infarctions (MIs), or any repeat revascularization.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione Ricerca e Innovazione Cardiovascolare ETS

Lead sponsor

Fundación EPIC

Collaborator

Source ClinicalTrials.gov
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