Clinical trial NCT06535568: Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB
Official title: International, Multicenter, Investigator-driven Randomized Clinical Trial to Assess the Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With Drug-coated Balloons
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: 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
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
Lead sponsor: Fondazione Ricerca e Innovazione Cardiovascolare ETS
Sponsor class: OTHER
Collaborators: name: Fundación EPIC
First posted: 2024-08-02
Enrollment: 416
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rate of major adverse cardiovascular events (MACE) at 12 months
timeFrame: 12 months
measure: Rate of clinically relevant bleeding events (Bleeding Academic Research Consortium 2, 3, or 5)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: