Evaluation Of Human Urinary Kallidinogenase in Acute Stroke Patients: Magnetic Resonance Spectrum and CT Perfusion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- N-acetylaspartate as measured on Magnetic Resonance Spectrum study on admission
研究概览
简要总结
Background: Acute ischemic stroke (AIS) is a leading cause of morbidity and mortality worldwide. Human urinary kallidinogenase (HUK), a glycoprotein extracted from male urine currently used in China for enhancing cerebral perfusion5, plays a neuroprotective role including promoting angiogenesis, enhancing cerebral perfusion and suppressing the inflammatory response in animals and in patients with respect to regulating the kallikrein-kinin system. In previous clinical research, neurological function scores and cerebral perfusion scans were largely used to evaluate the efficiency of HUK. However, the mechanisms of Further well-conducted, randomized controlled studies using HUK are currently lacking.
Objective: To assess the Human urinary kallidinogenase effects on brain metabolite and cerebral perfusion changes using magnetic resonance spectroscopy and CT perfusion in patients with AIS.
Methods: The investigators plan to do a single-centre randomized, double-blind, controlled trial in which ischemic stroke patients will be randomized to treatment with either HUK or regular treatment within 72 hours of symptom onset. The study includes two MRS and two CTP scannings (before and after 2 week treatment) for all randomized subjects.
The endpoints will include improvement of the NIH Stroke Scale (NIHSS) score from baseline, modified Rankin scale (mRS) score and Barthel index at 14 days.
EvHUKMRS will test the following hypotheses:
- HUK enhanced N-acetylaspartate (NAA) and cerebral blood flow (CBF) 14 days after treatment compared with control group.
- HUK group compared to control group when administered 72 hours after onset of AIS improves recovery and functional outcome as assessed by improvement of NIHSS score , mRS score and BI score on day 14 post-stroke.
A positive result will have a significant impact in the management of AIS and pave the way for future studies aimed at finding the optimal dose and formulation of HUK for treating acute ischemic stroke.
详细描述
A)Specific Primary Objective:
- To determine if HUK, administered within 72 hours of AIS onset is superior to regular treatment in improving NAA values and CBF on day 14 post stroke.
B) Specific Secondary Objectives:
- To determine if HUK, administered within 72 hours of AIS onset is superior to regular treatment in reducing neurological deficit and improving functional outcome on day 14 post stroke.
Recruitment of study subjects:
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
- 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
- 是
入选标准
- •ages ranging from 18 to 80 years
- •onset time less than 72 h, NIHSS score ≥4;
排除标准
- •patients with contraindication of venous thrombolysis
- •patients with encephalic bleeding disorder
- •patients with incomplete hepatic and renal function
- •patients with a medical history of peptic ulcer, haemorrhagic stroke, brain tumour or brain trauma
- •patients who could not coordinate with an MRS scan and
- •patients with vertebral basilar artery system infarction.
研究组 & 干预措施
Kallikrein group
Subjects receive kailikang treatment according to real clinical practice (suggest above 14 days treatment),0.15 peptide nucleic acids(PNA), once a day.
干预措施: Human urinary kallidinogenase (HUK) (Drug)
Control group
Patients in control group will receive foundation treatment, including aspirin® (100 mg/d), clopidogrel® (75 mg/d), and atorvastatin® (20 mg/d) for 14 days
干预措施: aspirin® , clopidogrel® , atorvastatin® (Drug)
结局指标
主要结局
N-acetylaspartate as measured on Magnetic Resonance Spectrum study on admission
时间窗: 14 days
NAA Admit
Creatine as measured on Magnetic Resonance Spectrum study on admission
时间窗: 14 days
Cr Admit
Cholineas measured on Magnetic Resonance Spectrum study on admission
时间窗: 14 days
Cho
次要结局
- The proportion of NIHSS(14 days)
- The proportion of mRS(14 days)
- The proportion of mordified Rankin Scale(14 days)
- Cerebral blood flow as measured on CT perfusion study on admission(14 days)
- Cerebral blood volume as measured on CT perfusion study on admission(14 days)
- Mean transit time as measured on CT perfusion study on admission(14 days)
- Time to peak as measured on CT perfusion study on admission(14 days)