Argatroban Plus R-tPA for Acute Posterior Circulation Infarction (AR-PCI): a Prospective, Random, Blinded Assessment of Outcome and Open Label Multi-center Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Proportion of mRS (0-1）
研究概览
简要总结
Acute ischemic stroke (AIS) is the most common type of stroke, which has high rate of morbidity, mortality and disability. A large number of studies have confirmed that the thrombolytic therapy can effectively open blood vessels and improve the functional prognosis of acute ischemic stroke. Therefore, all guidelines recommend giving thrombolysis treatment to acute ischemic stroke patients within 4.5 hours of onset. However, about 1/3 patients receiving thrombolysis will have good prognosis, while a large number of patients will still be disabled and even dead. How to improve the neurofunction prognosis of thrombolytic patients has been a hot topic in the world.
Recent studies have found that the combined application of argatroban and rt-PA in the treatment of acute anterior circulation infarction might improve the clinical prognosis and not significantly increase bleeding. Some studies have reported that the combined application of argatroban and rt-PA could improve the blood vessel opening rate, and prevent re-occlusion after opening.
Based on the discussion, the present study is designed to explore the efficacy and safety of argatroban plus rt-PA in the treatment of acute posterior circulation infarction.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old;
- •Diagnosis of posterior circulation ischemic stroke;
- •Time from onset to treatment ≤6 hours;
- •NIHSS: 4-25;
- •Signed informed consent by patient self or legally authorized representatives.
排除标准
- •History of stroke within 3 months;
- •History of intracranial hemorrhage;
- •Suspected subarachnoid hemorrhage;
- •Intracranial tumour, vascular malformation or arterial aneurysm;
- •Major surgery within 1 month;
- •Systolic pressure ≥180 mmHg or diastolic pressure ≥110 mmHg;
- •Platelet count < 105/mm3;
- •Heparin therapy or oral anticoagulation therapy within 48 hours;
- •Abnormal APTT;
- •Thrombin or Xa factor inhibitor;
- •Severe disease with a life expectancy of less than 3 months;
- •Blood glucose < 50 mg/dL (2.7mmol/L);
- •Patients who have received any other investigational drug or device within 3 months;
- •Researchers consider patients inappropriate to participate in the registry.
研究组 & 干预措施
Argatroban combined with rt-PA
干预措施: Argatroban combined with rt-PA (Drug)
rt-PA
干预措施: rt-PA (Drug)
结局指标
主要结局
Proportion of mRS (0-1）
时间窗: 90±7 days
次要结局
- Early neurological deterioration(48 hours)
- Proportion of mRS (0-2）(90±7 days)
- the occurence of stroke(90±7 days)
- symptomatic intracranial hemorrhage(36 hours)
研究者
Hui-Sheng Chen
Professor
General Hospital of Shenyang Military Region