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

Overview

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.

Interventions

• Drug Androtriol Injection (High-dose group)
  Participants will receive 30 mL of Androtriol Injection per dose, administered every 12 hours for 7 consecutive days. Each infusion will be administered over a period of 30±5 minutes.
• Drug Androtriol Injection (Low-dose group)
  Participants will receive 10 mL of Androtriol Injection combined with 20 mL of placebo (Hydroxypropyl Beta-Cyclodextrin Injection) per dose, administered every 12 hours for 7 consecutive days. Each infusion will be administered over a period of 30±5 minutes.
• Drug Hydroxypropyl-β-cyclodextrin injection
  Participants will receive 30 mL of Hydroxypropyl-β-cyclodextrin injection per dose, administered every 12 hours for 7 consecutive days. Each infusion will be completed within 30±5 minutes.

Primary outcome measures

• The proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90 days after stroke onset [Time frame: 90 days after stroke onset]

Secondary outcome measures (5)

• The modified Rankin Scale (mRS) scores at 90 days after stroke [Time frame: 90 days after stroke onset]
• The proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 90 days after stroke onset [Time frame: 90 days after stroke onset]
• The change of the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 14 days after stroke onset or at discharge [Time frame: Baseline, 14 days or at discharge]
• The change of Barthel Index (BI) scores at 30 days and 90 days after stroke onset [Time frame: Baseline, 30 days and 90 days after stroke onset]
• The change of EuroQol Five Dimensions Questionnaire (EQ-5D) scores at 30 days and 90 days after stroke onset [Time frame: Baseline, 30 days and 90 days after stroke onset]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06679322 · YC-6-PIIb-AIS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗