A study to evaluate safety and optimal dose/administration of adrenomedullin in patients with acute non-embolic ischemic stroke

IHARA MASAFUMI0 sites60 target enrollmentJanuary 8, 2020

Overview

No summary available.

Registry

who.int

Start Date

January 8, 2020

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

IHARA MASAFUMI

•1\) Patients who have given written informed consent from the patient or the sponsor to participate in the clinical trial
•2\) Patients of the following age
•(1\) Up to 6 patients in both cohorts: age between 20 and 75 at the time of obtaining consent
•(2\) In both cohorts, after age restriction has been lifted: Patients aged 20 to 90 at the time of consent acquisition
•3\) Patients who can start study drug administration within 24 hours after onset of ischemic stroke
•(If the time of onset is unknown, the time last seen normal is the time of onset.)
•4\) Patients with a new ischemic area confirmed by MRI\-DWI
•5\) Patients with NIHSS scores of 1 or above

•1\) Patients with ischemic stroke of embolic etiology
•2\) Patients who are likely to develop hemorrhagic transformation (patients with extensive ischemic stroke)
•3\) Patients who have premorbid mRS scores of 3 or more
•4\) Patients with active infections
•5\) Patients who have received or are scheduled to receive drugs or therapy (endovascular treatment, surgical treatment, etc.) not allowed to be used for the underlying disease
•6\) Patients with severe consciousness impairment (Japan Coma Scale 100 or more)
•7\) Patients with severe renal impairment (estimated GFR less than 30 mL / min / 1\.73m2\)
•8\) Patients with severe liver damage (transaminase AST (GOT) or ALT (GPT) 100 IU / L or more)
•9\) Patients diagnosed as having active intracranial bleeding disease (intracranial hemorrhage, subarachnoid hemorrhage, etc.) or ruptured cerebral aneurysm by head MRI taken after onset
•10\) Patients with severe stenosis and obstruction of the basilar artery, internal carotid artery, and middle cerebral artery horizontal part considered to be the cause of cerebral infarction targeted in this study