The Efficacy and Safety of Y-3 Intracalvariosseous Injection Bypassing Blood-brain Barrier Versus Intravenous Injection in the Treatment of Acute Large Hemispheric Infarction(SOLUTION-2)

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug, Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

A pilot study confirmed the feasibility and safety of neuroprotectant Y-3 intracalvariosseous(ICO) injection in patients with malignant middle cerebral artery infarction (mMCAI), showing a trend in improving 90-day functional scores compared to conventional treatment. The aim of this trial is to further investigate the efficacy and safety of ICO injection of Y-3 compared to intravenous injection in patients with acute large hemispheric infarction(LHI) who has contraindications of reperfusion therapy or have got poor reperfusion therapy outcomes.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 18≤Age≤80 years;

• First stroke or complete self-care before the onset of current stroke (mRS 0-1);

• Administration of drugs can be completed within 24h of the onset of signs and symptoms of neurological deficits (in patients with wake-up strokes or unwitnessed strokes, the time of onset is defined as the time of last normal presentation);

• Clinical symptoms, signs and imaging diagnosis of cerebral infarction in the area supplied by the middle cerebral artery, together with the following features:

‣ 16≤ NIHSS ≤32 points, and the sum of the scores of motor arm and motor leg is ≥6;

⁃ Imaging suggestive of core infarct area: apparent diffusion coefficient (ADC) values \<620×10\^-6mm\^2/s lesion volume on magnetic resonance imaging (MRI) diffusion-weighted imaging (DWI) sequences or cerebral blood flow (CBF) \<30% of volume 70-300 ml on computed tomography perfusion imaging (CTP) or an Alberta Stroke Program Early CT Score (ASPECTS) of 0-6, with inconsistent findings, the investigator is required to make a reasoned judgement by taking into account all the information (scanning time, the imaging method that best responds to the size of infarct, etc.) and record it.

• NIHSS score not improving or progressing after reperfusion therapy and total score still ≤32.

• Informed consent signed

Locations
Other Locations
China
Beijing Tiantan Hospital
RECRUITING
Beijing
North China University of Science and Technology Affiliated Hospital
RECRUITING
Tangshan
Tangshan Municipal Worker's Hospital
WITHDRAWN
Tangshan
Tianjin Huanhu hospital
RECRUITING
Tianjin
The first affiliated hospital of Wannan Medical College
RECRUITING
Wuhu
Shaanxi Provincial People's Hospital
RECRUITING
Xi'an
Contact Information
Primary
Yilong Wang, PhD+MD
yilong528@gmail.com
18842627325/13261655100
Time Frame
Start Date: 2024-04-22
Estimated Completion Date: 2027-03-15
Participants
Target number of participants: 134
Treatments
Experimental: ICO injection group
Y-3 ICO injection (dose was given as 32 ug/kg) once a day for 3 consecutive days, as well as standard treatment and management according to the related guidelines.
Active_comparator: intravenous injection group
Y-3 intravenous injection(dose was given as 40mg + 250ml normal saline), as well as standard treatment and management according to related guidelines.
Related Therapeutic Areas
Sponsors
Leads: yilong Wang

This content was sourced from clinicaltrials.gov