Hypertension induced by intravenous administration of norepinephrine to improve the prognosis of patients with neurological deterioration in the acute phase of an ischemic stroke

Trial details

Who runs it

Centre Hospitalier Universitaire De Bordeaux

Trial code

EU 2023-508704-37-00

Record updated

2026. szeptember 30.

Original description

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.Read full original descriptionShow less

Induced hypertension in acute PRogrESsive perforating artery Stroke Using peripheral dilute noREpinephrine

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).

Inclusion: 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.

Exclusion: Drugs with important interactions with norepinephrine: monoamine oxidase inhibitors (including reversible, non-selective agents such as linezolid), tricyclic antidepressants, entacapone. Pregnancy or breastfeeding; 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; Pre-Stroke Modified Rankin Score > 3; Large artery atherosclerosis (ipsilateral atherosclerotic stenosis > 50%), intra and extracranial dissection, or cardio-embolic stroke mechanisms; Significant arrhythmia including atrial fibrillation, acute coronary syndrome, significant congestive heart failure, hypertrophic cardiomyopathy; Requirement for anticoagulation in the first 7 days after randomization (except subcutaneous low molecular weight heparins for prevention of deep venous thrombosis); 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); Pregnancy or breastfeeding; Contraindication to brain Magnetic Resonance Imaging (MRI); Systolic blood pressure (SBP) > 200 mmHG and/or mean arterial pressure (MAP) ≥ 110mmHG at inclusion.

EU CTIS 2023-508704-37-00