Recruiting
Induced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine
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.
ClinicalTrials.gov IDNCT06059144
PhasePHASE3
Enrollment358
SponsorUniversity Hospital, Bordeaux
Age18 Years and older
SexALL
Conditions studied
Stroke, Acute, Stroke, Ischemic
About this study
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.
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 outcomes
- modified Rankin Scale (mRS) (Day 0)
- modified Rankin Scale (mRS) (Day 90)
Eligibility information
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
Study locations
- CHU de Bordeaux, Bordeaux, France
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-01.