Hypertension induced by intravenous administration of norepinephrine to improve the prognosis of patients with neurological deterioration in the acute phase of an ischemic stroke

Phase 1

• Conditions: Stroke; MedDRA version: 22.1Level: LLTClassification code: 10055221Term: Ischemic stroke Class: 10029205; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-508704-37-00
• Lead Sponsor: Centre Hospitalier Universitaire De Bordeaux

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-22
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 358

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, -Drugs with important interactions with norepinephrine: monoamine oxidase inhibitors (including reversible, non-selective agents such as linezolid), tricyclic antidepressants, entacapone. Pregnancy or breastfeeding, -Significant arrhythmia including atrial fibrillation, acute coronary syndrome, significant congestive heart failure, hypertrophic cardiomyopathy, -Pregnancy or breastfeeding., -Contraindication to brain Magnetic Resonance Imaging (MRI), -High risk of intracerebral hemorrhage defined on brain magnetic resonance imaging (MRI) by the presence of the following isolated or associated criteria: ?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 and 24h post-thrombolysis required brain imaging (CT or MRI) to exclude haemorrhagic transformation of acute ischemic stroke, -Requirement for anticoagulation in the first 7 days after randomization (except subcutaneous low molecular weight heparins for prevention of deep venous thrombosis), -Systolic blood pressure (SBP) > 200 mmHG 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, -Known hypersentivity to norepinephrine

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified