Using norepinephrine to induce hypertension in patients with acute ischemic stroke

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective trial evaluates the efficacy and safety of inducing hypertension using peripheral dilute norepinephrine in patients with acute ischemic stroke caused by perforating arteries. The study focuses on individuals who experience early neurological deterioration within 72 hours of stroke onset. By increasing cerebral perfusion pressure, the trial aims to restore blood flow in the ischemic penumbra, potentially improving patient outcomes. Participants will be randomized to receive the treatment or standard care, with outcomes assessed by blinded evaluators.

Why it matters

Who can join: the full rules

Inclusion 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 or ataxia score, whether this deterioration is transient or permanent.
* Time between early 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 Criteria:

* \- Pre-Stroke Modified Rankin Score \> 3
* Contraindication to brain Magnetic Resonance Imaging (MRI)
* High risk of intracerebral hemorrhage:

  * 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
* Requirement for anticoagulation in the first 7 days after randomization
* Systolic blood pressure (SBP) \> 180mmHG and/or mean arterial pressure (MAP) ≥ 110mmHG at inclusion
* Large artery atherosclerosis (ipsilateral atherosclerotic stenosis \> 50%), intra and extracranial dissection, or cardio-embolic stroke mechanisms
* Drugs with important interactions with norepinephrine: monoamine oxidase inhibitors (including reversible, non-selective agents such as linezolid), tricyclic antidepressants, entacapone.
* Pregnancy or breastfeeding

Where it's running

• CHU de Bordeaux
  Bordeaux, France Recruiting

Study contacts

• Study coordinator: Pauline RENOU
• Email: pauline.renou@chu-bordeaux.fr
• Phone: 05-56-79-55-20

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.