NCT04325932撤回4 期
Study of Urinary Kallikrein to Enhance Collateral Circulation in Symptomatic Intracranial Atherosclerosis: a Study Based on Whole-brain CTP
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
研究概览
简要总结
The purpose of this study is to determine whether Urinary Kallikrein has an additional effect on enhancing collateral circulation in symptomatic intracranial atherosclerotic patients under clopidogrel and aspirin dual antiplatelet therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Acute ischemic stroke or TIA within 72 hours;
- •Intracranial ICA, MCA M1 segment stenosis (>70%)
排除标准
- •>70% Stenosis in an intracranial artery other than the culprit artery.
- •>50% Stenosis of an extracranial carotid or vertebral artery on the ipsilateral side.
- •Perforator strokes based on MRI.
- •Non-atherosclerotic lesion, for example, moyamoya disease, vascular inflammatory disease due to infection, autoimmunity diseases, developmental or genetic abnormalities, for example, fibromuscular dysplasia, sickle-cell anaemia, suspected vasospasm.
- •Potential cardiac embolism as cause.
- •Intracranial haemorrhage within 6 weeks.
- •Concomitant intracranial tumour, aneurysm or arteriovenous malformation.
- •Known contraindications for heparin, aspirin, clopidogrel or contrast.
- •Haemoglobin <10 g/dL, blood platelet count <100 000, international normalisation ratio >1.5, or other uncorrectable coagulopathies.Impaired liver function (alanine aminotransferase or glutamic oxalacetic transaminase ≥ 3×upper limit of normal) or renal function (serum creatinie ≥ 1.5mg/dl);
- •A baseline modified Rankin Score of ≥
- •Life expectancy of <1 year due to the concomitant illness.
- •Pregnant or lactating women.
- •long-term statins users.
- •History of mental instability or dementia.
研究组 & 干预措施
Urinary Kallikrein group
Experimental
Urinary Kallikrein for injection, 0.15PNA IU,qd, for 2 weeks, administered within 96 hours after TIA or acute ischemic stroke, with basic therapies like dual antiplatelet therapy, blood pressure-lowering therapy and lipid-lowering therapy.
干预措施: Urinary Kallikrein (Drug)
结局指标
主要结局
the percentage of patients with modified Rankin Score (mRS) equivalent to or less than 2
时间窗: 3 months
次要结局
- NIHSS score(2 weeks, 1month)
- rLMC scale of Collateral circulation(2 weeks, 1 month)
- New stroke or transient ischemic attack(TIA)(6 months)
- Hemorrhageic complications(2 weeks, 1 month, 3 months, 6 months)
研究者
研究点 (1)
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