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โ† Trials
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Induced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine

RecruitingPhase 3Ages 18 Years - anyAllUniversity Hospital, Bordeaux
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In plain words

What the trial is, and whether it could suit you

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.

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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 โ‰ฅ 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 โ‰ฅ 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) โ‰ฅ 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
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What it tests

  • Peripheral intravenous norepinephrine
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Where

1 site
CHU de Bordeaux
Bordeaux, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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