Informations générales (source: ClinicalTrials.gov)
Induced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine
Interventional
Phase 3
University Hospital, Bordeaux (Voir sur ClinicalTrials)
novembre 2024
novembre 2027
13 septembre 2025
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| HOPITAL FOCH | BERTRAND LAPERGUE | 11/05/2026 07:26:32 | Contacter | ||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Bordeaux - Bordeaux - France | Pauline RENOU | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
-
- 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