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Recruiting NCT06059144

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

Phase III Interventional Stroke, Acute Stroke, Ischemic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peripheral intravenous norepinephrine.
Who it may be relevant to
Registry conditions: Stroke, Acute, Stroke, Ischemic. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

PRESSURE is a multicenter, prospective, randomized, open, blinded end-point assessed (PROBE) trial, that aims to evaluate the efficacy and safety of drug-induced hypertension using peripheral dilute norepinephrine, in patients with acute ischemic stroke in a perforating artery territory and experiencing early neurological deterioration.

Detailed description

Perforating artery strokes represent 25% of all ischemic strokes and is a well-known cause of progressive symptoms : 12 to 36% of cases experience early neurological deterioration in hours or days after stroke onset. A possible mechanism is hypoperfusion due to lack of a rapid development of collateral flow because of the terminal distribution of perforating arteries. Moreover, arterioles are maximally dilated within penumbra region, resulting in a cerebral autoregulation failure and a passive dependence of cerebral blood flow on arterial pressure. Thus, induced-hypertension therapy by using vasopressive agents is an attractive therapy to increase the cerebral perfusion pressure and therefore restore blood flow in the ischemic penumbra.

Interventions

  • Drug Peripheral intravenous norepinephrine
    Norepinephrine (dilution: 10µg/ml, initial dose: 0.04µg/kg/min) will be titrated until MAP is between 110 and 120mmHG (with a maximal systolic blood pressure of 210mmHG) Gradually decrease of norepinephrine will start after 24h of NIHSS stabilization.

Primary outcome measures

  • modified Rankin Scale (mRS) [Time frame: Day 0]
  • modified Rankin Scale (mRS) [Time frame: Day 90]
Secondary outcome measures (10)
  • modified Rankin Scale (mRS) [Time frame: Day 90]
  • modified Rankin Scale (mRS) [Time frame: Day 90]
  • NIHSS Score [Time frame: Day 0]
  • NIHSS Score [Time frame: Day 7]
  • Mortality [Time frame: Day 90]
  • Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) [Time frame: Day 90]
  • Hospital Anxiety and Depression Scale [Time frame: Day 90]
  • Proportion of patients presenting Acute coronary syndrome [Time frame: Day 7]
  • Proportion of patients presenting Congestive heart failure [Time frame: Day 7]
  • Proportion of patients presenting Tachyarrhythmia [Time frame: Day 7]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU de Bordeaux — Bordeaux

Identifiers

NCT: NCT06059144 · CHUBX 2022/23

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗