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

NCT06059144 | Recruiting Phase 3 DMC

• 1 other identifier: CHUBX 2022/23
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

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 norepinephrine, in patients with acute ischemic stroke in a perforating artery territory and experiencing early neurological deterioration.

Conditions

Stroke, Acute; Stroke, Ischemic

Outcome Measures

Primary Outcomes (2)

• modified Rankin Scale (mRS)

  Functional independence defined by modified Rankin scale 0-2 or return to pre-stroke modified Rankin scale, assessed at 90 days. The assessment of the clinical outcome at 90 (±15) days will be conducted by an independent qualified assessor (blinded to patient treatment allocation). The minimal value of the modified Rankin Scale is 0 (best outcome) and the maximum value is 6 (worst outcome).

  Day 0

• modified Rankin Scale (mRS)

  Functional independence defined by modified Rankin scale 0-2 or return to pre-stroke modified Rankin scale, assessed at 90 days. The assessment of the clinical outcome at 90 (±15) days will be conducted by an independent qualified assessor (blinded to patient treatment allocation). The minimal value of the modified Rankin Scale is 0 (best outcome) and the maximum value is 6 (worst outcome).

  Day 90

Secondary Outcomes (10)

• modified Rankin Scale (mRS)

  Day 90

• modified Rankin Scale (mRS)

  Day 90

• NIHSS Score

  Day 0

• NIHSS Score

  Day 7

• Mortality

  Day 90

Study Arms (2)

Induced hypertension using norepinephrine

EXPERIMENTAL

Standard care and 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. Standard care includes antithrombotic treatments according to the physician's choice and ESO recommendations

Drug: Peripheral intravenous norepinephrine

Standard care

NO INTERVENTION

Standard care includes antithrombotic treatments according to the physician's choice and ESO recommendations

Interventions

Peripheral intravenous norepinephrine DRUG

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.

Induced hypertension using norepinephrine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- 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
• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, France

RECRUITING

MeSH Terms

Conditions

Stroke; Ischemic Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Pauline RENOU

  University Hospital, Bordeaux

  STUDY CHAIR

Central Study Contacts

Pauline RENOU

CONTACT

05-56-79-55-20; pauline.renou@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: September 28, 2023
• Study Start: November 28, 2024
• Primary Completion (Estimated): August 28, 2027
• Study Completion (Estimated): November 28, 2027
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

FR (1)