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Not yet recruitingNCT06679322Updated Nov 7, 2024

The Androtriol Injection for the Treatment of Acute Ischemic Stroke

A Phase 2 interventional study of Androtriol Injection (High-dose group) and Androtriol Injection (Low-dose group) in Acute Ischemic Stroke, sponsored by Beijing Tiantan Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-07.

Sponsored by Beijing Tiantan Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Phase
Phase 2
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Ischemic Stroke

Keywords

  • Androtriol
  • Acute Ischemic Stroke
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 300 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Beijing Tiantan Hospital is the lead sponsor of 465 studies on the registry; 282 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Intervention Group (high-dose group)

    Androtriol injection (300 mg BID)

    Drug: Androtriol Injection (High-dose group)

  • Experimental
    Intervention Group (low-dose group)

    Androtriol injection (100 mg BID)

    Drug: Androtriol Injection (Low-dose group)

  • Placebo comparator
    Placebo

    Hydroxypropyl-β-cyclodextrin injection

    Drug: Hydroxypropyl-β-cyclodextrin injection

Interventions

  • DrugAndrotriol 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.

  • DrugAndrotriol 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.

  • DrugHydroxypropyl-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.

06

What researchers measure

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).

    Time frame: 90 days after stroke onset

Secondary outcomes

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

    The mRS denotes modified Rankin Scale, ranging from 0 (no neurologic deficit, no symptoms or completely recovered) to 6 (death).

    Time frame: 90 days after stroke onset

  2. The proportion of participants with a modified Rankin Scale (mRS) score of 0-2 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).

    Time frame: 90 days after stroke onset

  3. The change of the National Institutes of Health Stroke Scale (NIHSS) score from baseline at 14 days after stroke onset 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.

    Time frame: Baseline, 14 days or at discharge

  4. The change of Barthel Index (BI) scores at 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.

    Time frame: Baseline, 30 days and 90 days after stroke onset

  5. The change of EuroQol Five Dimensions Questionnaire (EQ-5D) scores at 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.

    Time frame: Baseline, 30 days and 90 days after stroke onset

Other outcomes

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

    Time frame: From the time of administration to day 90

  2. Incidence of significant adverse events and serious adverse events (SAE)

    Time frame: From the time of administration to day 90

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

    The Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST) criteria: Within 36 hours after thrombolysis, an increase of NIHSS score≥4 compare to baseline or the lowest NIHSS, with \> 30% infarction area.

    Time frame: 36 hours after thrombolysis

  4. All-cause mortality

    Time frame: From the time of administration to day 90

  5. Discontinuation of medication due to any reason or adverse events

    Time frame: From the time of administration to day 90

  6. The change of midline shift from baseline at 22-36 hours and 7 days after first treatment

    Time frame: Baseline, 22-36 hours, and 7 days after first treatment

  7. The change of lesion volume from baseline at 22-36 hours and 7 days after first treatment

    Time frame: Baseline, 22-36 hours, and 7 days after first treatment

  8. The change of edema volume on the lesion side from baseline at 22-36 hours and 7 days after first treatment

    Time frame: Baseline, 22-36 hours, and 7 days after first treatment

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06679322
Lead sponsor
Beijing Tiantan Hospital
Responsible party
Yongjun Wang (Chief Physician, Beijing Tiantan Hospital) — Principal investigator
First posted
Nov 7, 2024
Start date
Oct 31, 2024 (estimated)
Primary completion
Sep 30, 2025 (estimated)
Completion
Oct 30, 2025 (estimated)
Last update
Nov 7, 2024

Study contacts

Shuya Li, MD
Contact
shuyali85@163.com
86-10-59976117

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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