Clinical trial NCT06679322: The Androtriol Injection for the Treatment of Acute Ischemic Stroke
Official title: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Trial of Androtriol Injection for the Treatment of Acute Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Acute Ischemic Stroke
Keywords: Androtriol
Acute Ischemic Stroke
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2024-11-07
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter, randomized, double-blind, placebo-controlled, phase IIb clinical trial of Androtriol injection for the treatment of acute ischemic stroke. The goal of this trial is to explore the efficacy and safety of different doses of Androtriol injection in patients with acute ischemic stroke (AIS) who received vascular recanalization treatment within 24 hours of symptom onset.

Participants will receive a low-dose Androtriol injection (100 mg BID), a high-dose Androtriol injection (300 mg BID), or a placebo intravenously within 24 hours of stroke onset. They will be treated twice daily (every 12 hours) for 7 days, with a total of 14 doses over the course of the study. Each infusion will last approximately 30±5 minutes.


Eligibility criteria: Inclusion Criteria:

1. Age 18- 80 years, male or female；
2. mRS score ≤1 prior to this onset;
3. Planning to receive or have received intravascular recanalization therapy at our center within 24h of onset;
4. To complete the first administration of the investigational medication within 24h of onset;
5. NIHSS（National Institutes of Health Stroke Scale）score≥6 prior to intravascular recanalization;
6. Informed consent.

Exclusion Criteria:

1. Intracranial hemorrhagic diseases, including hemorrhagic stroke, epidural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, etc.;
2. Severe disorders of consciousness: NIHSS 1a≥2 points;
3. Large infarct core (ASPECTS \<6, or\>1/3 of MCA territory involved, as evidenced by CT or MRI);
4. Severe hypertension: systolic blood pressure ≥185mmHg or diastolic blood pressure ≥110mmHg after medication control;
5. History of severe kidney disease (such as dialysis), or eGFR \<45 mL/min/1.73m²;
6. History of severe liver disease, or ALT, AST levels more than 3 times of the upper limit of normal, or bilirubin more than 3 times of the upper limit of normal;
7. Cardiovascular diseases, such as complete atrioventricular block, history of congestive heart failure (CHF), or heart function classification≥NYHA Class III;
8. Critically ill patients with an expected lifespan≤90 days;
9. History of epilepsy or epilepsy-like symptoms during stroke or severe psychiatric disorders, intellectual disability, or dementia;
10. History of intracranial hemorrhage;
11. Severe injury or surgery history within 3 months of onset;
12. Have received\>1 dose of neuroprotective drugs after this onset, such as edaravone, edaravone dexborneol injection, ginkgo lactone, ginkgo diterpene glucamine，etc;
13. Allergy to the investigational drug (either the active ingredient androtriol or the excipient hydroxypropyl beta-cyclodextrin) or similar chemical structure drugs;
14. Pregnant or breastfeeding;
15. Participation in other clinical trials within 3 months of onset;
16. Unsuitable for participating in this study judged by investigator.

Primary outcomes:
measure: The proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90 days after stroke onset
timeFrame: 90 days after stroke onset
Secondary outcomes:
measure: The modified Rankin Scale (mRS) scores at 90 days after stroke
timeFrame: 90 days after stroke onset
measure: The proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 90 days after stroke onset
timeFrame: 90 days after stroke onset
measure: The change of the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 14 days after stroke onset or at discharge
timeFrame: Baseline, 14 days or at discharge
measure: The change of Barthel Index (BI) scores at 30 days and 90 days after stroke onset
timeFrame: Baseline, 30 days and 90 days after stroke onset
measure: The change of EuroQol Five Dimensions Questionnaire (EQ-5D) scores at 30 days and 90 days after stroke onset
timeFrame: Baseline, 30 days and 90 days after stroke onset
Other outcomes:
measure: Incidence of adverse events (AE) and treatment-related adverse events (TEAE)
timeFrame: From the time of administration to day 90
measure: Incidence of significant adverse events and serious adverse events (SAE)
timeFrame: From the time of administration to day 90
measure: Symptomatic intracranial hemorrhage (sICH) within 36 hours after thrombolysis (SITS-MOST criteria)
timeFrame: 36 hours after thrombolysis
measure: All-cause mortality
timeFrame: From the time of administration to day 90
measure: Discontinuation of medication due to any reason or adverse events
timeFrame: From the time of administration to day 90
measure: The change of midline shift from baseline at 22-36 hours and 7 days after first treatment
timeFrame: Baseline, 22-36 hours, and 7 days after first treatment
measure: The change of lesion volume from baseline at 22-36 hours and 7 days after first treatment
timeFrame: Baseline, 22-36 hours, and 7 days after first treatment
measure: The change of edema volume on the lesion side from baseline at 22-36 hours and 7 days after first treatment
timeFrame: Baseline, 22-36 hours, and 7 days after first treatment
Locations:
Study officials:
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