Using norepinephrine to induce hypertension in patients with acute ischemic stroke

Induced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine

This study is testing if using norepinephrine to raise blood pressure can help people who have had an acute ischemic stroke and are showing early signs of worsening symptoms.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 358 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University Hospital, Bordeaux (Academic / other)
• Locations: 1 site (Bordeaux)
• Trial ID: NCT06059144 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who have experienced an acute ischemic stroke in a perforating artery territory and show early neurological deterioration.

Not a fit: Patients with a pre-stroke Modified Rankin Score greater than 3 or those at high risk for intracerebral hemorrhage may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve recovery and outcomes for patients suffering from acute ischemic strokes.

How similar studies have performed: While the approach of induced hypertension in stroke patients is being explored, this specific methodology using peripheral dilute norepinephrine is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Bordeaux

• CHU de Bordeaux — Bordeaux, France (Recruiting)

Study contacts

• Study coordinator: Pauline RENOU

Conditions Stroke, Acute; Stroke, Ischemic