Acute ischemic stroke
Conditions
Interventions
Experimental:30 ml Androtriol injection will be given intravenously in 30 minutes every 12 hours for 7 consecutive days.
Placebo:30 ml Hydroxypropyl-beta-cyclodextrin injection will be given intravenously in 30 minutes every 12 hours for 7 consecutive days.
Sponsors
The Army Medical Center of the Chinese People’s Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Age 18 -80 years. 2.Acute ischemic stroke (AIS) with occlusion of the internal carotid artery (ICA) and/or the M1 and/or the M2 segments of the middle cerebral artery (MCA). 3. Pre-stroke Modified Rankin Scale (mRS) Score=6 at admission. 5. Non-Contrast CT (NCCT) Alberta Stroke Program Early CT Score (ASPECTS)>=6,and meet both of the following indicators: a. an initial infarct volume=15 mL; b. a ratio of volume of ischemic tissue to initial infarct volume of 1.8 or more*; Definitions:a region with reduced cerebral blood flow (=6 and (CBV-MTT)-ASPECTS>=2. 6.Endovascular mechanical thrombectomy (EVT) via femoral artery puncture initiated within 24 hours of stroke onset. 7.Successful revascularization of the target vessel and modified Thrombolysis in Cerebral Infarction (mTICI) score>=2b. 8. Informed consent was signed by the subject and/ or the legal representative.
Exclusion criteria
Exclusion criteria: 1.Unable to undergo CT or MR. 2. Confirmed Intracranial hemorrhage (ICH) or subarachnoid hemorrhage (SAH). 3.History of severe renal disease. 4.History of severe liver disease, or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3 times the upper limit of normal (ULN), or total bilirubin >2 times the ULN. 5.Malignant tumor. 6.History of epilepsy or seizure-like symptoms at the onset of stroke. 7.Abnormal coagulation function (except for an elevated International Normalized Ratio (INR) of 2.0–3.0 due to warfarin therapy), or coagulation disorder. 8.Severe injury or surgery within the past 3 months; 9.Heart disease or abnormalities as following : a.Ranking III or IV heart failure in New York Heart Association (NYHA) Class. b. History of congestive heart failure (CHF). c. Complete atrioventricular (AV) block. 10.Uncontrolled severe hypertension (>185/110 mmHg ). 11.Fasting plasma glucose 22.2 mmol/L. 12.Psychiatric illness. 13.History of drug, alcohol, or substance abuse. 14.Allergy to the investigational drug or drugs with similar chemical structures. 15.Pregnant or lactating female, or their potential mate. 16.Participation in other clinical trial within 3 months. 17.Unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| good outcome (90 days mRS 0-2); | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-hour, 72-hour, 7-day, 14-day changes in NIHSS scores compared to baseline;Change in core infarct volume over 7 days compared to baseline;All-cause mortality within 90 days after onset ; | — |
Countries
China
Contacts
Public ContactMeng Zhang
Department of Neurology, Daping Hospital, Army Medical Center of PLA
Outcome results
None listed