CTIS2023-508704-37-00进行中（未招募）1 期
Induced hypertension in acute PRogrESsive perforating artery Stroke Using peripheral dilute noREpinephrine - CHUBX 2022/23
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 358
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Acute ischemic stroke < 72 h in a perforating artery territory on brain MRI, -Early neurological deterioration or fluctuation, attested by the neurologist in charge, defined by a = 3-point increase in global NIHSS score OR a 2-point increase on motor or ataxia score, whether this deterioration is transient or permanent, -Time between early neurological deterioration and randomization < 6 hours, -Age = 18 years, -Contraception required in women of childbearing potential (Intra-uterine device, hormonal contraception associated with inhibition of ovulation (combined or progestogen-only; oral, intravaginal or transdermal), Female Sterilization, Vasectomised partner, sexual abstinence), -Beneficiary of a health insurance system
排除标准
- •-Pre-Stroke Modified Rankin Score > 3, -Drugs with important interactions with norepinephrine: monoamine oxidase inhibitors (including reversible, non-selective agents such as linezolid), tricyclic antidepressants, entacapone. Pregnancy or breastfeeding, -Significant arrhythmia including atrial fibrillation, acute coronary syndrome, significant congestive heart failure, hypertrophic cardiomyopathy, -Pregnancy or breastfeeding., -Contraindication to brain Magnetic Resonance Imaging (MRI), -High risk of intracerebral hemorrhage defined on brain magnetic resonance imaging (MRI) by the presence of the following isolated or associated criteria: ?cerebral microbleeds >10 ?non traumatic focal superficial siderosis ?hemorrhagic transformation of the present ischemic stroke ?previous history of intracerebral hemorrhage (symptomatic or asymptomatic identified on brain MRI) ?intracranial vascular malformation or tumor with suspected risk of rupture or bleeding, -Prior intravenous thrombolysis < 24 hours and 24h post-thrombolysis required brain imaging (CT or MRI) to exclude haemorrhagic transformation of acute ischemic stroke, -Requirement for anticoagulation in the first 7 days after randomization (except subcutaneous low molecular weight heparins for prevention of deep venous thrombosis), -Systolic blood pressure (SBP) > 200 mmHG and/or mean arterial pressure (MAP) = 110mmHG at inclusion, -Large artery atherosclerosis (ipsilateral atherosclerotic stenosis > 50%), intra and extracranial dissection, or cardio-embolic stroke mechanisms, -Known hypersentivity to norepinephrine
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