Argatroban Combined With Antiplatelet Versus Antiplatelet for Acute Mild or Moderate Ischemic Stroke With Large-artery Atherosclerosis: a Prospective, Single Center Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Proportion of 1 or more increase in NIHSS
研究概览
简要总结
Intravenous thrombolysis is considered as the first choice for ischemic stroke. In the recent years, endovascular therapy is demonstrated to be effective to treat ischemic with big vessel occlusion. However, only a minority of patients can get intravenous thrombolysis or endovascular therapy due to the restricted time window and strict indications. Dual antiplatelet has been demonstrated to be effective in the patients with high risk of TIA or minor ischemic stroke (NIHSS<4). But there is still stroke progression although dual antiplatelet. The ischemic stroke patients with NIHSS > 3 has been recommended to give aspirin in most guidelines. Of those patients, mild to moderate stroke patients (3<NIHSS<10) will result in the poor outcomes if the progression occurs. In addition, large artery atherosclerosis (LAA) stroke is prone to progress. So, we argue that the mild to moderate stroke with LAA should be give more intensive antiplatelet. In the present study, argatroban combined with antiplatelet therapy (3-5 days) is used to treat the proposed patients to investigate the safety and effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Age 18-80 years old;
- •Clear diagnosis of ischemic stroke patients with head CT or MRI examination;
- •The time of onset is less than 72 hours;
- •NIHSS score is less than 12 points;
- •the large artery atherosclerosis etiology
- •Signed informed consent.
排除标准
- •Hemorrhagic stroke or mixed stroke;
- •Patients with planned thrombolytic therapy;
- •Serious diseases such as severe infection or liver, kidney, hematopoietic system, endocrine system, etc.;
- •The history of stroke and had serious sequelae (mRS> 1);
- •Allergic to aspirin/clopidogrel and argatroban;
- •ischemic stroke caused by other causes, such as small vessel lesions, cardiogenic embolism, arterial dissection, vasculitis and other cerebral infarction;
- •Previous history of cerebral hemorrhage;
- •It is expected to use other anti-platelet agents or non-steroidal anti-inflammatory agents that affect platelet function;
- •within 3 months of gastrointestinal bleeding or major surgery;
- •any unqualified patients judged by researchers.
研究组 & 干预措施
Argatroban combined with antiplatelet
干预措施: Argatroban plus dual antiplatelet (Drug)
结局指标
主要结局
Proportion of 1 or more increase in NIHSS
时间窗: 7 days
early neurological deterioration is defined as 1 or more increase in NIHSS
次要结局
未报告次要终点
研究者
Hui-Sheng Chen
Director of the Department
General Hospital of Shenyang Military Region