A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Trial of Androtriol Injection for the Treatment of Acute Ischemic Stroke
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 300
- Primary Endpoint
- The proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90 days after stroke onset
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Intervention Group (high-dose group)
Androtriol injection (300 mg BID)
Intervention: Androtriol Injection (High-dose group) (Drug)
Intervention Group (low-dose group)
Androtriol injection (100 mg BID)
Intervention: Androtriol Injection (Low-dose group) (Drug)
Placebo
Hydroxypropyl-β-cyclodextrin injection
Intervention: Hydroxypropyl-β-cyclodextrin injection (Drug)
Outcomes
Primary Outcomes
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
The mRS denotes modified Rankin Scale, ranging from 0 (no neurologic deficit, no symptoms or completely recovered) to 6 (death).
Secondary Outcomes
- 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)
Investigators
Yongjun Wang
Chief Physician
Beijing Tiantan Hospital