Status:
RECRUITING
Induced Hypertension in Acute PRogrESsive Perforating Artery Stroke Using Peripheral Dilute noREpinephrine
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Stroke, Acute
Stroke, Ischemic
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 n...
Detailed Description
Perforating artery strokes represent 25% of all ischemic strokes and is a well-known cause of progressive symptoms : 12 to 36% of cases experience early neurological deterioration in hours or days aft...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
November 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 28 2027
Estimated Enrollment :
358 Patients enrolled
Trial Details
Trial ID
NCT06059144
Start Date
November 28 2024
End Date
November 28 2027
Last Update
January 9 2025
Active Locations (1)
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1
CHU de Bordeaux
Bordeaux, France