Efficacy and Safety of Shortening Dual Antiplatelet Therapy Duration with IVUS Guidance in PCI Patients: a Multicenter, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 3,566
- 试验地点
- 1
- 主要终点
- Net Adverse Cardiovascular and Cerebrovascular Events (NACCE) within 12 Months Post-PCI
研究概览
简要总结
This study is designed to assess the efficacy and safety of de-escalating dual antiplatelet therapy (DAPT) at 1 month compared to the standard 12 months of therapy in patients undergoing percutaneous coronary intervention (PCI) guided by intravascular ultrasound (IVUS). The main outcomes measured will include major adverse cardiovascular and cerebrovascular events (NACCE), bleeding events, and target vessel failure (TVF). The goal is to evaluate whether a shorter duration of DAPT is non-inferior to the standard 12-month regimen in preventing ischemic events while reducing the incidence of bleeding.
详细描述
This multicenter, double-blind, randomized controlled trial will evaluate the clinical outcomes of DAPT de-escalation at 1 month compared to 12 months, in patients who have undergone PCI with drug-eluting stent (DES) implantation. The study aims to optimize post-PCI treatment duration while reducing associated risks such as bleeding complications. Intravascular ultrasound (IVUS) will be used to guide stent placement and optimize results, especially in high-risk, complex cases.
Participants will be randomly assigned to two groups:
- One month of DAPT, followed by monotherapy with a P2Y12 inhibitor.
- Standard 12 months of DAPT. Patients will be followed for 12 months after the intervention to track cardiovascular events, bleeding complications, and overall safety.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older.
- •Patients undergoing percutaneous coronary intervention (PCI) with drug-eluting stents (DES).
- •Patients with the following clinical indications for PCI:
- •Unstable Angina: Prolonged chest pain at rest, new-onset angina within the past 2 months, or increasing frequency/severity of angina attacks.
- •Acute Myocardial Infarction (MI): With or without ST-elevation.
- •Chronic Coronary Syndrome: Requiring coronary revascularization.
- •Patients who agree to participate and provide informed consent.
排除标准
- •Inability to Provide Informed Consent: Patients who are unable or unwilling to provide consent.
- •Neurological Complications: Stroke or any permanent neurological deficits within the last 3 months.
- •Coronary Artery Bypass Graft Surgery: History of CABG surgery.
- •Planned Surgery: Patients who have surgeries planned within the next 12 months.
- •Severe Chronic Kidney Disease: Patients with an estimated glomerular filtration rate (eGFR) of less than 20 ml/min/1.73 m² or patients on dialysis.
- •Chronic Anticoagulation Therapy: Patients requiring chronic oral anticoagulation (e.g., warfarin, DOACs) beyond DAPT.
- •Thrombocytopenia: Platelet count less than 100,000/mm³.
- •Contraindications to Antiplatelet Therapy: Allergy or intolerance to aspirin or P2Y12 inhibitors.
- •Liver Disease: Patients with cirrhosis or significant liver dysfunction.
- •Limited Life Expectancy: Patients with a life expectancy of less than 12 months due to other non-cardiac conditions.
- •Other Medical Conditions: Any condition that might interfere with adherence to the study protocol or follow-up schedule.
研究组 & 干预措施
Group 1 (1-Month DAPT): DAPT De-escalation (Intervention Group)
Patients in this group will receive DAPT (aspirin and a P2Y12 inhibitor) for 1 month, followed by monotherapy with a P2Y12 inhibitor for the remaining 11 months.
干预措施: DAPT de-escalation (Drug)
结局指标
主要结局
Net Adverse Cardiovascular and Cerebrovascular Events (NACCE) within 12 Months Post-PCI
时间窗: 12 months of enrollment
NACCE is a composite of major adverse cardiovascular events (MACEs) and cerebrovascular events, and any significant bleeding event (classified according to BARC 2-5). Cumulative risk of NACCE will be compared between the 1-month DAPT and 12-month DAPT groups.
次要结局
- 12-month Target Vessel Failure (TVF) Rate(12 months of enrollment)
- 12-month Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)(12 months of enrollment)
- Major Bleeding Events Classified by BARC (Bleeding Academic Research Consortium) Scale(12 months of enrollment)
- Clinical Characteristics of PCI Patients at Baseline (Descriptive Analysis of Demographics and Clinical Data)(12 months of enrollment)
研究者
Vu Hoang Vu
Head of Interventional Cardiology Department, PhD MD
University of Medicine and Pharmacy at Ho Chi Minh City