NCT07712445招募中不适用
Platelet Membrane-coated Tenecteplase to Improve Thrombolytic Efficacy by Targeting Thrombus
The First Affiliated Hospital with Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2026年6月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Thrombolysis rate
研究概览
简要总结
Tenecteplase (TNK) is the latest generation of specific thrombolytic drugs independently developed in China. This study aims to investigate the thrombolytic efficacy of platelet membrane-coated tenecteplase (PM-TNK) on human ex vivo arterial thrombi, and to explore the inhibitory effects of plasma from patients receiving antiplatelet therapy on its thrombolytic activity, thereby evaluating the future clinical application value of PM-TNK.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- 是
入选标准
- •For CAD patients:
- •Age 18-75 years old, body weight ≥45kg, regardless of gender; Patients with suspected coronary artery disease scheduled for coronary angiography or interventional therapy.
- •Take aspirin and ticagrelor maintenance dose ≥3 days, or loading dose of aspirin (300mg) and ticagrelor (180mg) ≥12 hours;
- •For healthy volunteer:
- •Age 18-75 years old, body weight ≥45kg, regardless of gender
排除标准
- •For CAD patients
- •Previous thrombolytic therapy with TNK;
- •Those who are enrolled in other clinical trials;
- •Those who were deemed ineligible by other investigators.
- •For healthy volunteer:
- •1. Currently taking any medication that may affect platelet function, such as antiplatelet drugs or nonsteroidal anti-inflammatory drugs.
- •Individuals with blood disorders, active bleeding or a tendency to bleed, including platelet count <100×10^9/L, hemoglobin <100g/L, or recent bleeding in the digestive system or urinary tract within one month.
- •Individuals with impaired liver or kidney function, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels above the upper limit of normal reference range, and estimated glomerular filtration rate (eGFR) <90 mL/min/1.73m^2 (calculated based on the CKD-EPI equation).
- •Recent (within one month) severe trauma, surgery, or head injury.
- •Pregnant or lactating women.
- •Those who are enrolled in other clinical trials;
- •Those who were deemed ineligible by other investigators.
结局指标
主要结局
Thrombolysis rate
时间窗: 60 min
Thrombolysis rate (%) = \[(initial clot weight - final clot weight) / initial clot weight\] × 100%.
次要结局
未报告次要终点
研究者
Chunjian Li
Chief physician
The First Affiliated Hospital with Nanjing Medical University
研究点 (1)
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