A Phase IIa trial of Androtriol Injection for the Treatment of Acute Ischemic Stroke -a Prospective, Multicenter, Randomized, and Placebo-controlled Study

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

1. A clinical diagnosis of acute ischemic stroke in the middle cerebral artery (MCA) territory (ACA territory involvement in addition to primary MCA territory stroke is acceptable). A large hemispheric infarction defined as: NCCT/MRI found more than 50% MCA blood supply area or CTP found 2/3 MCA blood supply area involved, and CTA/MRA found internal carotid artery/middle cerebral artery M1 segment occlusion. 2. mRS<2 before symptom onset; 3.15=NIHSS=25; 4. The study drug initiated within 12 hours of symptom onset; 5. 18=Age=85 years; 6. Informed consent was signed by the subject or the legal representative.

Exclusion Criteria

1. Decompressive craniectomy was completed or planned before randomization; 2. Successful endovascular recanalization before initiation of the study drug (reduction of at least 4 points in the NIHSS score, or mRS=1 after thrombolysis; mTICI=2b after thrombectomy); 3. Unable to undergo MRI examination (e.g., due to internal pacemaker or automatic defibrillator); 4. With symptomatic cerebral infarction in both cerebral hemispheres; 5. Presence of clinical signs of brain herniation formation, e.g., unilateral or bilateral pupil dilation and fixation, or loss of brainstem reflexes; 6. CT/MRI indicates PH2 type of cerebral hemorrhage; 7. History of severe kidney disease (e.g., dialysis), or eGFR<45 mL/min/1.73m2; 8. History of severe liver disease, or ALT>3 times the upper limit of normal; 9. Pregnancy or breastfeeding; 10. Patients with malignant tumors or other critical illnesses; 11. History of epilepsy or epileptoid symptoms at stroke onset; 12. History intracranial hemorrhage; 13. History of hypotension or three consecutive blood pressure measurements below 90/60 mmHg; 14.Severe injury and surgery within the past 3 months; 15.Complete atrioventricular block; 16.Prolonged QT interval: QTcb male=450ms; Female=470ms; Heart rate<50 beats/min; 17. With New York Heart Association (NYHA) heart function rating class II or more severe, or history of congestive heart failure(CHF); 18. Current problem or experience of drug or alcohol abuse; 19. Allergy to study drugs or drugs with similar chemical structures ; 20. Participation in other clinical trials within 3 months before this study.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Distribution of modified Rankin Scale (mRS) score at 90 day after randomization;Midline shift (mm) at 72h and 10d after randomization (compared with 24 hours);

Secondary Outcome Measures

Name	Time	Method
Proportion of mRS Score 0-4 in subjects without undergoing decompressive craniectomy at 90 day after randomization;Change of National Institutes of Health Stroke Scale (NIHSS) score at 10d after randomization (compared with baseline);The proportion of mRS score 0-2 at 30d and 90d after randomization;Changes of Barthel index (BI) scores on Activities of daily living scale at 30d and 90d after randomization;The score changes of EuroQol health index scale EQ-5D at 30d and 90d after randomization;All-cause death (90±7 days after randomization);Change in lesion volume (cm3) 72h, 10d after randomization (compared to within 24h);Volume change of ipsilateral edema (cm3) at 72h and 10d after randomization (compared with within 24h);The proportion of subjects who met the criteria for decompressive craniectomy (an increase of =1 point in the standard disturbance of consciousness score NIHSS 1a and a midline shift of =5mm within 2 days of onset) within 72h after randomization;