NCT02041650已完成4 期
Plaque Erosion: A New in Vivo Diagnosis and Paradigm Shift in the Treatment of Patients With Acute Coronary Syndrome
Yu Bo1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2014年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Reduction of thrombus burden by OCT
研究概览
简要总结
This protocol describes a pilot study intended to test the hypothesis that patients with acute coronary syndrome (ACS) caused by plaque erosion can be stabilized by effective antithrombotic treatment without stent implantation, thereby avoiding both early and late complications related to percutaneous coronary intervention (PCI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or non-pregnant women >18 years of age and < 75 years of age
- •Patients undergo cardiac catheterization for ACS. Patients with STEMI, NSTEMI, and UAP will be included. STEMI will be defined as continuous chest pain for >30 minutes, arrival at the hospital within 12 hours from chest pain onset, ST-segment elevation >0.1 mV in at least two contiguous leads, or new left bundle-branch block on the 12-lead electrocardiogram (ECG), and elevated cardiac markers (troponin T/I or creatine kinase-MB). NSTEMI will be defined as a progressive crescendo pattern of angina or angina at rest, in the absence of ST-segment elevation on the 12-lead ECG, with elevated cardiac markers. UAP will be defined as new onset angina, progressive crescendo pattern of angina, or angina at rest.
- •Culprit lesion located in a native coronary artery
- •TIMI flow grade 3 and diameter stenosis < 70% on angiogram
- •Definite erosion defined by OCT
- •Patients able to provide written informed consent
排除标准
- •Left ventricular ejection fraction < 30%.
- •Life expectancy < 1 year.
- •Contraindication to the contrast media.
- •Creatinine level > 2.0 mg/dL or end-stage kidney disease.
- •Serious liver dysfunction.
- •Patients with hemodynamic or electrical instability (including shock).
- •Any contraindication against the use of ticagrelor.
- •Investigator considers the patient is not suitable.
研究组 & 干预措施
Patients with ACS treated medically
Other
干预措施: Ticagrelor (Drug)
结局指标
主要结局
Reduction of thrombus burden by OCT
时间窗: 30 days
The efficacy will be assessed by 50% reduction in thrombus burden by OCT at 1 month.
次要结局
- Cardiovascular adverse events(30 days and 12 months)
研究者
Yu Bo
Director of Cardiology of The 2nd Affiliated Hospital of Harbin Medical University
Harbin Medical University
研究点 (1)
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