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

Not Applicable

Not yet recruiting

• Conditions: Coronary Disease; Heart Diseases; Cardiovascular Diseases; Myocardial Ischemia; Atherosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Immunosuppressive Agents; P2Y12 Inhibitor; Coronary Artery Disease
• Interventions: Device: Drug-coated balloon; Drug: Single antiplatelet therapy (SAPT); Drug: Dual antiplatelet therapy (DAPT)

• Registration Number: NCT06535568
• Lead Sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-07-30
• Study First Submitted QC: 2024-07-30
• Status Verified: 2024-08
• Study First Posted: 2024-08-02
• Last Update Submitted: 2024-08-12
• Last Update Posted: 2024-08-14
• Study Start: 2024-10-10
• Primary Completion: 2025-10-10
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 416

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Rate of clinically relevant bleeding events (Bleeding Academic Research Consortium 2, 3, or 5)	12 months	Superiority of SAPT vs. DAPT in terms of clinically relevant bleeding events (BARC 2, 3, or 5) at 12 months.
Rate of major adverse cardiovascular events (MACE) at 12 months	12 months	Non-inferiority of SAPT vs. DAPT in terms of MACE, a composite of all-cause mortality, target vessel revascularization-TVR, target vessel spontaneous MI at 12 months, after successful DCB angioplasty.