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

Recruiting now · Phase 3

Conditions studied: Stroke, Acute, Stroke, Ischemic

In brief

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.

Key facts

Study ID

NCT06059144

Run by

University Hospital, Bordeaux

People needed

358

Starts

2024-11-28

Expected to finish

2027-11-28

Last updated by the study team

2025-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• - 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

Where it is running

• CHU de Bordeaux — Bordeaux, France (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.