2024-519706-13-00招募中4 期
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
- 4 期
- 状态
- 招募中
- 入组人数
- 506
- 试验地点
- 20
- 主要终点
- Primary endpoint of the study will be the rate of Net Adverse Clinical Events (NACE) at 12 months, defined as the composite of MACE and clinically relevant bleeding events (BARC 2, 3, or 5), for which superiority of the SAPT arm over DAPT is hypothesized.
研究概览
简要总结
The primary objective of the study is to verify the superiority of SAPT vs. DAPT in terms of Net Adverse Clinical Events (NACE), defined as the composite of MACE and clinically relevant bleeding events (BARC 2, 3 or 5) at 12 months. We thus suppose that SAPT may provide similar benefits to DAPT regarding rate of MACE, and may offer improved net clinical benefit in terms of NACE due to reduced bleeding risk.
研究设计
- 分配方式
- Randomized
- 主要目的
- 12 Months Experimental Period
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels
- •De novo coronary lesions in vessels with diameter >=2.0 and <=4.0 mm (visual estimation)
- •Stable or unstable coronary syndromes
- •Informed consent to participate in the study given by the patient or impartial witness
- •Male and female patients age ≥ 75 years or at high bleeding risk
排除标准
- •Stent implantation during index or recent (<6 months) procedure
- •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
- •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
- •Full-blown thyrotoxicosis
- •Patients with a very high risk of thrombosis
- •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.
结局指标
主要结局
Primary endpoint of the study will be the rate of Net Adverse Clinical Events (NACE) at 12 months, defined as the composite of MACE and clinically relevant bleeding events (BARC 2, 3, or 5), for which superiority of the SAPT arm over DAPT is hypothesized.
Primary endpoint of the study will be the rate of Net Adverse Clinical Events (NACE) at 12 months, defined as the composite of MACE and clinically relevant bleeding events (BARC 2, 3, or 5), for which superiority of the SAPT arm over DAPT is hypothesized.
次要结局
- All-cause death (Expected Rate: 3-5%)
- Q-wave MI (Expected Rate: 0.5-1%)
- Any MI (Expected Rate: 3-4%)
- TLR (Expected Rate: 2-3%)
- TVR (Expected Rate: 3-4%)
- Procedural success (final % stenosis <30%, distal TIMI 3 flow and absence of inhospital major adverse events); (Expected Rate: 95%)
- Patient-oriented composite endpoint (PoCE), a composite of all-cause death, all MIs, or any repeat revascularization
- Cardiovascular and cardiac death (Expected Rate: 1-2%)
- Acute vessel occlusion (ARC criteria); (Expected Rate: 4-6%)
- Transfusion rates (Expected Rate: 1-2%)
- Functional Status and QoL will be assessed using a validated questionnaire with EQ-5D-5L at baseline, 1 month, 6 months, and 12 months. Rate for QoL/Functional Status: (Improvement: ≥5% increase in score from baseline; Deterioration: ≥5% decrease in score from baseline; No Change: ±5% change from baseline)
- BARC 2, 3, or 5 bleedings (superiority in study group is expected)
研究者
Sara Malakouti
Scientific
Fondazione Ricerca e Innovazione Cardiovascolare
研究点 (20)
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