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

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: Norepinephrine

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