TOLERANCE STUDY OF N-ACETYLCYSTEINE FOR THROMBOLYSIS IN THE ACUTE PHASE OF ISCHEMIC STROKE / ETUDE DE TOLERANCE DE LA N-ACETYLCYSTEINE POUR LA THROMBOLYSE A LA PHASE AIGUË DE L'INFARCTUS CEREBRAL
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Symptomatic intracranial hemorrhagic transformation
研究概览
简要总结
The primary objective of the study is to assess the safety of N-Acetylcysteine as a thrombolytic agent in acute ischemic stroke, especially regarding the risk of hemorrhagic transformation.
详细描述
Preclinical studies demonstrated that N-Acetylcysteine (NAC) is able to break von Willebrand Factor (VWF) multimers by bisulfide bond reduction. Since thrombi in stroke patients are rich in VWF, NAC could be used as a thrombolytic agent during the acute phase. This study aims at assessing the safety of NAC in combination with alteplase (rt-PA) at the acute phase of ischemic stroke.
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 86 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient presenting with an acute ischemic stroke (non lacunar) as assessed by cerebral imaging (either CT or MRI), with or without visible vessel occlusion.
- •Patient eligible to intravenous thrombolysis according to current criteria, including patients who will also benefit from endovascular treatment (if eligible).
- •Personal or familial consent to participate in the study.
排除标准
- •Known hypersensitivity to N-Acetylcysteine or to any excipient from the formulation.
- •Coma and/or NIHSS <4 or ≥
- •Daily treatment with Nitrovasodilator before the inclusion.
- •Known asthma or chronic obstructive pulmonary disease requiring bronchodilatators or steroids.
- •Participation to another interventional study if it requires administration of an experimental treatment in the first 3 days after NAC treatment.
- •Women of childbearing age (age < or = to 50)
- •Known history of prior treatment with vitamin-K antagonist or direct oral anticoagulant.
- •Known history of severe hepatopathy including cirrhosis, portal hypertension (esophageal varices) and evolutive hepatopathy.
研究组 & 干预措施
N-Acetylcysteine 150 mg/kg
Single intravenous injection of N-Acetylcysteine (150 mg/kg in 15 minutes).
干预措施: N-Acetyl cysteine (Drug)
结局指标
主要结局
Symptomatic intracranial hemorrhagic transformation
时间窗: 22 to 36 hours after treatment
Rate of symptomatic hemorrhagic transformation according to the SITS-MOST criteria: a local or remote parenchymal hemorrhage on imaging 22 to 36 hours after treatment or earlier if the imaging scan was performed due to clinical deterioration combined with a neurological deterioration of \>4 NIHSS points from baseline or from the lowest NIHSS score between baseline and 24 hours or leading to death within 24 hours.
次要结局
- Treatment related side effects(Up to 3 months after treatment)
- Mortality and functional independence(3 months after treatment)
- Extracranial hemorrhagic events(Up to 3 months after treatment)
- Early neurological improvement(24 hours after treatment)
- Plasma VWF multimers(Before, at 3 hours and at 24 hours after treatment)