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Hypertension induced by intravenous administration of norepinephrine to improve the prognosis of patients with neurological deterioration in the acute phase of an ischemic stroke
EU CTIS ID: 2023-508704-37-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- - 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
You likely can't join if
- - 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
See the full eligibility criteria
- - 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
- - 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.