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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - \- 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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.

Locations (1)

CHU de Bordeaux
Bordeaux, France