2023-508704-37-00招募中3 期
Induced hypertension in acute PRogrESsive perforating artery Stroke Using peripheral dilute noREpinephrine
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 358
- 试验地点
- 13
- 主要终点
- Functional independence defined as modified Rankin Scale (mRS) 0-2, or return to pre-stroke mRS, assessed at 90 days
研究概览
简要总结
The main objective of PRESSURE trial is to compare the 90-day functional independence rate (modified Rankin Scale [mRS]) between standard care and peripheral dilute norepinephrine and standard care alone in patients with acute progressive perforating artery stroke.
The estimand referred to this main objective, to the primary outcome measure, and to the primary analysis is the adjusted odds ratio of the modified Rankin Scale (mRS) 0-2, or return to pre-stroke mRS, at 90 days, between standard care plus peripheral dilute norepinephrine and standard care alone in patients with acute progressive perforating artery stroke, whatever the intercurrent events occurring during follow-up (treatment policy strategy).
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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 (including hand motricity) or ataxia score, whether this deterioration is transient or permanent
- •Time between the last 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
- •Large artery atherosclerosis (ipsilateral atherosclerotic stenosis > 50%), intra and extracranial dissection, or cardio-embolic stroke mechanisms
- •Known hypersentivity to norepinephrine
- •Poor venous access not allowing norepinephrine administration in accordance with the protocol’s administration criteria (except if indication for placement of a long catheter as part as routine care)
- •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
结局指标
主要结局
Functional independence defined as modified Rankin Scale (mRS) 0-2, or return to pre-stroke mRS, assessed at 90 days
Functional independence defined as modified Rankin Scale (mRS) 0-2, or return to pre-stroke mRS, assessed at 90 days
次要结局
- - Two outcomes will be used to assess 90-day functional outcomes: Ordinal (shift) modified Rankin scale at 90 days, and rate of 90-day excellent functional outcome (mRS 0-1)
- - Early neurological improvement defined as a reduction of at least 3 points on the National Institutes of Health Stroke Scale (NIHSS) at the end of NorEpinephrine (NE) infusion and at 7 days compared to the NIHSS at the NE initiation, or a NIHSS score of 0 or 1 at the end of NE infusion and at 7 days, evaluated by a stroke neurologist
- - Mortality from any cause at 90 days
- - Primary Care Post-Traumatic Stress Disorder Screen for DSM-5 (PC-PTSD-5) at 90 days
- - Hospital Anxiety and Depression (HAD) Scale at 90 days
- - Montreal Cognitive Assessment (MOCA) at 90 days
- - The main predictive factor of interest is the achievement of the target pressure (at least 24h with a PAM between 110 and 120mmH).
- - Symptomatic intracerebral hemorrhage defined by parenchymal hematoma type 2 combined with an increase in the NIHSS score of at least 4 points.
- - Norepinephrine (NE) extravasation associated with tissue injury requiring medical or surgical intervention (cf 10. Management of adverse events): peripheral intravenous must be assessed on initiation and every 1 hour while NE administration by nurses.
- - Acute coronary syndrome at 7 days
- - Congestive heart failure at 7 days
- - Tachyarrhythmia at 7 days
- - Headache, during NE infusion.
- - Chest pain during NE infusion.
- - Bradycardia
- - Dysuria during NE infusion.
- - Dyspnea during NE infusion.
- - The length of in-hospital stay will be measured from the date of admission in the emergency unit and the date of hospital discharge.
- - Rehabilitation will comprise need of hospitalization and length of stay in rehabilitation centers.
研究者
Investigateur Coordonnateur
Scientific
Centre Hospitalier Universitaire De Bordeaux
研究点 (13)
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