NCT06683131尚未招募4 期
IMpact of PCSK9 inhibitoR initiatiOn Before Percutaneous Coronary Intervention on Coronary microVascular Dysfunction and Events for Acute Myocardial Infarction: a Multi-center, Open-label, Randomized, Controlled Trial
The Affiliated Hospital of Xuzhou Medical University13 个研究点 分布在 1 个国家目标入组 1,160 人开始时间: 2025年11月20日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 1,160
- 试验地点
- 13
- 主要终点
- Rate of major adverse cardiovascular events (MACEs)
研究概览
简要总结
The goal of this clinical trial is to learn if drug tafolecimab works to treat participants with acute myocardial infarction (AMI) scheduled for primary percutaneous coronary intervention (PCI). It will also learn about the safety of drug tafolecimab. The main questions it aims to answer are:
- Does drug tafolecimab lower the risk of 1-year major adverse cardiovascular events?
- Does drug tafolecimab improve the coronary microvascular dysfunction?
- What medical problems do participants have when administering drug tafolecimab by injection? Researchers will compare the results administering drug tafolecimab or not to see if drug tafolecimab works to treat AMI.
Participants will:
- Administer drug tafolecimab by injection or not every month for 12 months
- Receive the standard of care of AMI
- Complete the measurement of coronary angiography-derived microcirculation resistance index after PCI
- Complete cardiac magnetic resonance after PCI if available
- Visit the clinic at 1,6,12 months after the first administration for checkups and tests
- Report any discomfort, event or queries at any time
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-75 years old
- •AMI diagnosed according to the latest guidelines, including ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction (NSTEMI)
- •The requirement for STEMI was that primary PCI was scheduled within 12 hours of onset.
- •The requirement for NSTEMI was that coronary angiography was scheduled within 2 hours for very high-risk participants and within 24 hours for high-risk participants .
- •Regardless of baseline LDL-C levels
- •Participants voluntarily took part in this study and signed informed consent
排除标准
- •Previous or ongoing treatment for any PCSK9i
- •Allergy to PCSK9i, statins, or any of the drug ingredients used during the trial
- •History of hemorrhagic cerebrovascular disease
- •History of old myocardial infarction/chronic heart failure
- •History of PCI or coronary artery bypass grafting (CABG) or preparation for CABG
- •Above Killip level II
- •Prolonged cardiopulmonary resuscitation (>20min)
- •Definite mechanical complications (including perforation of the interventricular septum, or rupture of the papillary tendon bundle or the left ventricular free wall)
- •malignant arrhythmia
- •Severe uncontrolled infection, bleeding disorder, end-stage renal disease, severe liver disease, endocrine dysfunction, or the expected less than 1 year survival of malignant tumors
- •Pregnant or lactating women
- •Participate in other clinical trials
研究组 & 干预措施
PCSK9 inhibitor (PCSK9i) group
Experimental
Participants receive PCSK9i tafolecimab and standard of care (SoC) of acute myocardial infarction
干预措施: Tafolecimab (Drug)
结局指标
主要结局
Rate of major adverse cardiovascular events (MACEs)
时间窗: From enrollment to 1 year after primary percutaneous coronary intervention
MACEs including cardiovascular death, nonfatal myocardial infarction, unplanned ischemia-driven revascularization, nonfatal stroke, hospitalization for heart failure
次要结局
- Number of participants with coronary microvascular dysfunction (CMD)(3-7 days after primary percutaneous coronary intervention)
- Concentration of low density lipoprotein cholesterol (LDL-C)(Both 1 month and 1 year after primary percutaneous coronary intervention)
- Rate of malignant arrhythmia(1 month after primary percutaneous coronary intervention)
研究者
研究点 (13)
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