NCT06769256招募中4 期
Effects of Intracoronary Recombinant Human TNK Tissue-type Plasminogen Activator Versus Tirofiban on Myocardial Perfusion and Clinical Prognosis in Patients With ST-segment Elevation Myocardial Infarction and High Thrombus Burden: a Multicenter, Randomized, Controlled, Single-blind, Non-inferior Study
Henan Institute of Cardiovascular Epidemiology1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年1月1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
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Corrected TIMI frame count (CTFC)
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy and safety of intracoronary rhTNK-tPA or Tirofiban in patients with ST-segment elevation myocardial infarction and high thrombus burden. The main questions it aims to answer are:
- Is the efficacy of intracoronary rhTNK-tPA non-inferior to intracoronary Tirofiban for the treatment of ST-segment elevation myocardial infarction in patients wiht high thrombus burden?
- Does intracoronary rhTNK-tPA increase the incidence of bleeding events?
This multicenter RCT study plans to enroll 300 patients, who are randomly divided into two groups: intracoronary rhTNK-tPA or Tirofiban by 1:1. The primary efficacy endpoint was post-PCI corrected TIMI frame count (CTFC). Major adverse events (death, recurrent myocardial infarction, ischemic stroke, or hospitalization for heart failure) were observed at 1 year follow-up.
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
- Single (Participant)
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
- •Age 18-75 years old;
- •STEMI within 12 hours of onset;
- •TIMI flow grade 0-2 or TIMI thrombus grade ≥4 after thrombus aspiration or balloon dilation
- •Radial artery access
排除标准
- •A functional coronary collateral supply (Rentrop grade≥2) to the infarctrelated artery
- •Known or suspected old myocardial infarction of target vessels
- •Rescue PCI
- •Cardiogenic shock
- •Contraindications to Tirofiban or rhTNK-tPA
- •Severe hepatic and renal insufficiency (alanine aminotransferase ≥5 upper limit of normal; estimated glomerular filtration rate <30ml/min/1.73m2, or on dialysis)
- •Prolonged (> 10 minutes) cardiopulmonary resuscitation
- •Definite mechanical complications (including ventricular septal perforation, or rupture of the Papillary tendon bundle, or rupture of the left ventricular free wall)
- •Severe chronic obstructive pulmonary disease or respiratory failure
- •Severe infection
- •Neurological disorders
- •Malignant tumors or other pathophysiological conditions with an expected survival time of less than 1 year
- •Pregnant or lactating women
研究组 & 干预措施
Intracoronary rhTNK-tPA
Experimental
干预措施: rhTNK-tPA, 4-8 mg (Drug)
Intracoronary Tirofiban
Active Comparator
干预措施: Tirofiban (Drug)
结局指标
主要结局
Corrected TIMI frame count (CTFC)
时间窗: At the end of Percutaneous Coronary Intervention procedure
次要结局
- TIMI flow grade(At the end of Percutaneous Coronary Intervention procedure)
- Complete ST-segment resolution (STR)(1 hour post PCI procedure)
- Left ventricular ejection fraction (LVEF)(Baseline, 1 month, 6 months and 12 months)
- A composite of all-cause death, recurrent myocardial infarction, ischemic stroke, and hospitalization for heart failure(1 month, 6 months and 12 months)
- Bleeding events according to the BARC bleeding classification(At hospital discharge, an average of 2 days after primary PCI, 1 month, 6 months and 12 months)
研究者
Chuanyu Gao
Director
Henan Institute of Cardiovascular Epidemiology
研究点 (1)
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