The Androtriol Injection for the Treatment of Acute Ischemic Stroke

Phase 2

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Androtriol Injection (High-dose group); Drug: Androtriol Injection (Low-dose group); Drug: Hydroxypropyl-β-cyclodextrin injection

• Registration Number: NCT06679322
• Lead Sponsor: Beijing Tiantan Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-29
• Study Start: 2024-10-31
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-06
• Last Update Submitted: 2024-11-06
• Study First Posted: 2024-11-07
• Last Update Posted: 2024-11-07
• Primary Completion: 2025-09-30
• Study Completion: 2025-10-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group (high-dose group)	Androtriol Injection (High-dose group)	Androtriol injection (300 mg BID)
Intervention Group (low-dose group)	Androtriol Injection (Low-dose group)	Androtriol injection (100 mg BID)
Placebo	Hydroxypropyl-β-cyclodextrin injection	Hydroxypropyl-β-cyclodextrin injection

Primary Outcome Measures

Name	Time	Method
The proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90 days after stroke onset	90 days after stroke onset	The mRS denotes modified Rankin Scale, ranging from 0 (no neurologic deficit, no symptoms or completely recovered) to 6 (death).

Secondary Outcome Measures

Name	Time	Method
The modified Rankin Scale (mRS) scores at 90 days after stroke	90 days after stroke onset	The mRS denotes modified Rankin Scale, ranging from 0 (no neurologic deficit, no symptoms or completely recovered) to 6 (death).
The proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 90 days after stroke onset	90 days after stroke onset	The mRS denotes modified Rankin Scale, ranging from 0 (no neurologic deficit, no symptoms or completely recovered) to 6 (death).
The change of the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 14 days after stroke onset or at discharge	Baseline, 14 days or at discharge	Scores on the National Institutes of Health Stroke Scale (NIHSS) range from 0 to 42, with higher scores indicating more severe stroke.
The change of Barthel Index (BI) scores at 30 days and 90 days after stroke onset	Baseline, 30 days and 90 days after stroke onset	The Barthel Index for Activities of Daily Living (ADL) assesses functional independence, generally in stroke patients. The higher the score, the more independent the patient is in completing the measured ADLs.
The change of EuroQol Five Dimensions Questionnaire (EQ-5D) scores at 30 days and 90 days after stroke onset	Baseline, 30 days and 90 days after stroke onset	The EQ-5D assesses quality of life across five domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each domain is scored on a scale from 1 to 3, with lower scores (closer to 1) indicating better health outcomes.