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Clinical Trials in France / NCT06059144
Recruiting Phase 3

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

NCT06059144 · tracked via the Priya Life Science France tracker
Phase
Phase 3
Started
2024-11-28
Last updated
2025-01-09

Condition(s) studied

Stroke, AcuteStroke, Ischemic

Investigational drug(s) / intervention(s)

Peripheral intravenous norepinephrine

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHU de Bordeaux Bordeaux France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06059144 on ClinicalTrials.gov ↗ ← All trials in France