Induced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine
University Hospital, Bordeaux
358 participants
Nov 28, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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 Criteria14
- \- 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
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06059144