๐ฌIn 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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ 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 โฅ 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 โฅ 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 โฅ 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) โฅ 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
๐
What it tests
- Peripheral intravenous norepinephrine
CHU de Bordeaux
Bordeaux, France
๐ค 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.