2023-508704-37-00RecruitingPhase 3
Hypertension induced by intravenous administration of norepinephrine to improve the prognosis of patients with neurological deterioration in the acute phase of an ischemic stroke
Induced hypertension in acute PRogrESsive perforating artery Stroke Using peripheral dilute noREpinephrine
Source: EU CTIS (euclinicaltrials.eu) · Last updated 30 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 358 (estimated)
- First submitted
- 22 Mar 2024
- Start date
- 8 Nov 2024
- Lead sponsor
- Centre Hospitalier Universitaire De Bordeaux
- Diseases
- Stroke
- EU CT number
- 2023-508704-37-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 358
- 18 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a recent stroke in a small deep brain artery whose symptoms are getting worse. It tests adding norepinephrine through a vein to standard care.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Acute ischemic stroke less than 72 hours old in a perforating artery area on brain MRI, with worsening symptoms (NIHSS up 3 points or more, or motor or ataxia score up 2 points) in the last 6 hours before randomization
- Earlier treatment
- Must not have had intravenous thrombolysis less than 24 hours earlier, unless brain imaging after 24 hours rules out bleeding; no need for anticoagulation in the first 7 days (except subcutaneous low molecular weight heparins)
Main reasons for not taking part
- Pre-stroke Modified Rankin Score above 3
- Stroke from large artery atherosclerosis (stenosis above 50%), dissection or a heart clot
- High risk of bleeding in the brain on MRI
- Significant arrhythmia including atrial fibrillation, acute coronary syndrome, or significant heart failure
- Pregnancy or breastfeeding
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (18)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier Universitaire D'Angers | Angers | France | Recruiting |
| Centre Hospitalier de la Cote Basque | Bayonne | France | Recruiting |
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | France | Recruiting |
| Centre Hospitalier Sud Francilien | Corbeil Essonnes Cedex | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Garches | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Le Kremlin-Bicetre | France | Recruiting |
| Centre Hospitalier Universitaire De Lille | Lille Cedex | France | Recruiting |
| Centre Hospitalier Regional De Marseille | Marseille | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier | Montpellier Cedex 5 | France | Recruiting |
| CHRU de Nancy | Nancy | France | Recruiting |
| Centre Hospitalier Universitaire De Nantes | Nantes Cedex 1 | France | Recruiting |
| Centre Hospitalier Sainte Anne Paris | Paris | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 10 | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 13 | France | Recruiting |
| Assistance Publique Hopitaux De Paris | Paris Cedex 18 | France | Recruiting |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | France | Recruiting |
| Hospital Foch | Suresnes | France | Recruiting |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.