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 (PICCOLETO IV-EPIC 38)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 576
- 主要终点
- Rate of Net Adverse Clinical Events (NACE) at 12 months
研究概览
简要总结
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.
详细描述
The purpose of the PICCOLETO IV-EPIC 38 study is to observe and evaluate the efficacy and safety of single antiplatelet therapy (SAPT) after successful PCI with the Essential Pro drug-coated balloon in native coronary artery disease in vessels with a diameter between 2.0 and 4.0 mm, compared to routine dual antiplatelet therapy (DAPT). Patients aged 75 years or older, or those at high bleeding risk, with stable or unstable coronary syndromes will be enrolled and randomized in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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);
- •History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage;
- •Acute gastrointestinal ulcers;
- •Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding);
- •Severe renal impairment (eGFR < 30 mL/min);
- •Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT/AST > 2 x ULN or total bilirubin >1.5 x ULN);
- •Severe cardiac failure (NYHA grade III or IV);
- •Combination with methotrexate at doses of 15 mg/week or more;
- •Patients with baseline neutrophil counts < 1500 cells/mm³;
- •Breastfeeding women;
- •Full-blown thyrotoxicosis;
- •Patients with a very high risk of thrombosis.
研究组 & 干预措施
Single antiplatelet therapy
干预措施: Drug-coated balloon (Device)
Single antiplatelet therapy
干预措施: Single antiplatelet therapy (SAPT) (Drug)
Dual antiplatelet therapy
干预措施: Drug-coated balloon (Device)
Dual antiplatelet therapy
干预措施: Dual antiplatelet therapy (DAPT) (Drug)
结局指标
主要结局
Rate of Net Adverse Clinical Events (NACE) at 12 months
时间窗: 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.
次要结局
- Rate of clinically relevant bleeding events (BARC 2, 3, or 5)(12 months)
- Procedural success rate immediately post-PCI(Post-PCI)
- Patient-oriented composite endpoint (PoCE)(12 months)