Safety and Efficacy of Urinary Kallidinogenase for Large Artery Atherosclerosis Acute Ischemic Stroke：a Multicentre, Prospective, Randomised, Open-label, Blinded-Endpoint Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 986
- 试验地点
- 1
- 主要终点
- Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.
详细描述
Currently, evidence regarding the safety and efficacy of urinary kallidinogenase treatment in patients with acute ischemic stroke lacks, and few of related studies were large-scale and high-quality. Thus, this study was designed to evaluate the safety and efficacy of urinary kallidinogenase treatment in patients with large artery atherosclerotic acute ischemic stroke.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years old;
- •Acute anterior circulation large artery atherosclerotic cerebral infarction (according to TOAST classification) within 48h of onset; NIHSS score ≥6, ≤15;
- •Moderate to severe stenosis or occlusion of offending vessels;
- •The mRS Score ≤2 before onset;
- •Subjects or their legal representatives agreed to the treatment and signed the informed consent form.
排除标准
- •Transient ischemic attack;
- •Patients who planned or had received emergency reperfusion therapy (including intravenous thrombolysis and emergency thrombectomy);
- •Severe disturbance of consciousness:GCS ≤8;
- •Patients who previously received angiotensin-converting enzyme inhibitor (ACEI) drugs regularly;
- •Refractory hypertension: systolic blood pressure ≥200 mmHg or diastolic blood pressure ≥110 mmHg; hypotension: systolic blood pressure < 90 mmHg or diastolic blood pressure < 60 mmHg;
- •Liver dysfunction (ALT/AST >1.5 × upper limit of normal [ULN]), renal dysfunction (Cr >1 × ULN);
- •Coagulopathy (prolonged INR (>1.5) or prolonged APTT (>2 folds);
- •Cardioembolic stroke or high-risk factors of cardioembolic stroke identified by investigators (atrial fibrillation, cardiac mural thrombus, cardiomyopathy, etc.);
- •Special populations such as pregnant and lactating women, patients with life expectancy less than 3 months, or patients unable to complete the study for other reasons;
- •Unwilling to be followed up or poor treatment compliance;
- •Participating in other clinical investigators, or had participated in other clinical investigators within 3 months before enrollment;
- •Other conditions considered by the investigator to be inappropriate for enrollment.
研究组 & 干预措施
Urinary Kallidinogenase group
Patients are treated with urinary kallidinogenase and guideline-prescribed basic medical therapy.
干预措施: Urinary kallidinogenase for injection (Drug)
Control group
Patients are only treated with guideline-prescribed basic medical therapy.
干预措施: Guideline-prescribed medical therapy (Other)
结局指标
主要结局
Proportion of patients with Modified Rankin Scale (mRS) Score 0-2 at 90 days
时间窗: 90 days
Modified Rankin Scale (mRS) ranged from 0 to 6, a low value represents a better outcome.
次要结局
- National Institute of Health Stroke Scale (NIHSS) at 7days.(7days)
- Incidence of ischemic stroke within 90 days.(0-90days)
- Adverse events occurring in the course of the treatment.(0-7days)
研究者
Yi Yang
Associated Dean of the First Hospital of Jilin University
The First Hospital of Jilin University