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Study on Norepinephrine for Improving Outcomes in Patients with Acute Progressive Stroke

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for patients who have experienced an ischemic stroke, which is a type of stroke caused by a blockage in the blood vessels supplying blood to the brain. The treatment being tested involves the use of a medication called norepinephrine, which is administered through an intravenous infusion. Norepinephrine is a chemical that can help increase blood pressure, and in this study, it is used in a diluted form to potentially improve the outcomes for patients who are experiencing neurological deterioration during the acute phase of their stroke.

The purpose of the study is to determine if adding norepinephrine to the standard care for stroke patients can improve their recovery and functional independence after 90 days. Participants in the study will receive either the standard care alone or the standard care plus the norepinephrine infusion. The study will monitor the patients' progress over a period of 90 days to assess their recovery and any changes in their condition.

Throughout the study, various aspects of the patients' health will be evaluated, including their neurological improvement, any side effects from the treatment, and their overall well-being. The goal is to see if the use of norepinephrine can lead to better outcomes for patients who have suffered from an acute ischemic stroke, potentially offering a new approach to treatment that could enhance recovery and quality of life.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as having an acute ischemic stroke within 72 hours, experiencing early neurological deterioration, and being at least 18 years old.

    Women of childbearing potential must use contraception during the study.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either standard care or standard care plus norepinephrine.

    The time between early neurological deterioration and randomization must be less than 6 hours.

  3. Step 3

    Treatment administration

    If assigned to the norepinephrine group, the medication is administered intravenously as a solution for infusion.

    The goal is to achieve a target blood pressure for at least 24 hours.

  4. Step 4

    Monitoring and assessment

    During the infusion, regular monitoring is conducted to assess blood pressure and any potential side effects such as headache, chest pain, or changes in heart rate.

    The infusion is evaluated by a stroke neurologist, and adjustments are made as necessary.

  5. Step 5

    Follow-up evaluations

    Functional independence is assessed at 90 days using the modified Rankin Scale (mRS).

    Additional evaluations include cognitive assessments and screening for anxiety and depression.

  6. Step 6

    Completion of the study

    The study concludes with a final assessment of outcomes, including any improvements in neurological function and overall health status.

    The length of hospital stay and any rehabilitation needs are documented.

Who can join the trial?

6 criteria

  • The patient must have had an acute ischemic stroke in a specific area of the brain within the last 72 hours. An ischemic stroke happens when a blood vessel supplying blood to the brain is blocked.
  • The patient must show early signs of worsening or changes in their neurological condition, confirmed by a neurologist. This is defined by an increase of 3 or more points in the overall NIHSS score or a 2-point increase in movement or coordination scores. The NIHSS score is a tool used to measure the severity of a stroke.
  • The time between the early worsening of the condition and the start of the trial must be less than 6 hours.
  • The patient must be 18 years old or older.
  • Women who can have children must use contraception. This includes methods like an intra-uterine device, hormonal contraception that stops ovulation, female sterilization, having a partner who has had a vasectomy, or choosing not to have sex.
  • The patient must be covered by a health insurance system.

Who cannot join the trial?

7 criteria

  • Patients who have had a recent **stroke**. A stroke is when blood flow to a part of the brain is stopped or reduced, causing brain cells to die.
  • Patients who are not within the age range specified for the study.
  • Patients who are not able to give their own consent to participate in the study.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have allergies or reactions to the study medication or similar drugs.
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Investigated drugs

Norepinephrine is a medication used in this trial to help manage blood pressure. It is administered in a diluted form through a peripheral vein. The goal is to induce hypertension, which means raising the blood pressure, in patients who have experienced an acute progressive perforating artery stroke. This approach is being tested to see if it can improve the chances of patients regaining functional independence within 90 days after the stroke.

What is already known about the treatment

Norepinephrine – This medication is administered through an intravenous infusion, typically in a diluted form, to manage blood pressure in medical settings. It is currently being studied in clinical trials for its potential use in treating acute progressive perforating artery stroke. The main therapeutic indication for norepinephrine in this context is to induce hypertension to improve blood flow in stroke patients. At the molecular level, norepinephrine works by stimulating alpha and beta-adrenergic receptors, leading to vasoconstriction and increased heart rate, which raises blood pressure. It is classified as a vasopressor and sympathomimetic agent.

Investigated diseases

Stroke – A stroke occurs when the blood supply to part of the brain is interrupted or reduced, preventing brain tissue from getting oxygen and nutrients. This can lead to brain cells beginning to die within minutes. There are two main types of stroke: ischemic, caused by a blockage in an artery, and hemorrhagic, caused by a blood vessel leaking or bursting. Symptoms can include sudden numbness or weakness, especially on one side of the body, confusion, trouble speaking, and difficulty walking. The progression of a stroke can vary, with some individuals experiencing rapid onset of severe symptoms, while others may have more gradual changes. Immediate medical attention is crucial to minimize brain damage and potential complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508704-37-00Protocol codeCHUBX 2022/23Estimated enrolment358 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).