The Androtriol Injection for the Treatment of Acute Ischemic Stroke

NCT ID: NCT06679322

Last Updated: 2024-11-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-10-30

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.

Conditions

Acute Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Group (high-dose group)

Androtriol injection (300 mg BID)

Group Type: EXPERIMENTAL

Androtriol Injection (High-dose group)

Intervention Type: DRUG

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.

Intervention Group (low-dose group)

Androtriol injection (100 mg BID)

Group Type: EXPERIMENTAL

Androtriol Injection (Low-dose group)

Intervention Type: DRUG

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.

Placebo

Hydroxypropyl-β-cyclodextrin injection

Group Type: PLACEBO_COMPARATOR

Hydroxypropyl-β-cyclodextrin injection

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yongjun Wang

Chief Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Shuya Li, MD

Role: CONTACT

shuyali85@163.com

86-10-59976117

Other Identifiers

YC-6-PIIb-AIS

Identifier Type: -

Identifier Source: org_study_id