The Androtriol Injection for the Treatment of Acute Ischemic Stroke

NCT06679322 | Not Yet Recruiting Phase 2

• 1 other identifier: YC-6-PIIb-AIS
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Keywords

Androtriol; Acute Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• The proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 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).

  90 days after stroke onset

Secondary Outcomes (5)

• The modified Rankin Scale (mRS) scores at 90 days after stroke

  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

  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

  Baseline, 14 days or at discharge

• 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 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

Other Outcomes (8)

• Incidence of adverse events (AE) and treatment-related adverse events (TEAE)

  From the time of administration to day 90

• Incidence of significant adverse events and serious adverse events (SAE)

  From the time of administration to day 90

• Symptomatic intracranial hemorrhage (sICH) within 36 hours after thrombolysis (SITS-MOST criteria)

  36 hours after thrombolysis

Study Arms (3)

Intervention Group (high-dose group)

EXPERIMENTAL

Androtriol injection (300 mg BID)

Drug: Androtriol Injection (High-dose group)

Intervention Group (low-dose group)

EXPERIMENTAL

Androtriol injection (100 mg BID)

Drug: Androtriol Injection (Low-dose group)

Placebo

PLACEBO COMPARATOR

Hydroxypropyl-β-cyclodextrin injection

Drug: Hydroxypropyl-β-cyclodextrin injection

Interventions

Androtriol Injection (High-dose group) 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 (high-dose group)

Androtriol Injection (Low-dose group) 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.

Intervention Group (low-dose group)

Hydroxypropyl-β-cyclodextrin injection 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Central Study Contacts

Shuya Li, MD

CONTACT

86-10-59976117; shuyali85@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 7, 2024
• Study Start: October 31, 2024
• Primary Completion: September 30, 2025
• Study Completion: October 30, 2025
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share