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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group (high-dose group) | Experimental | Androtriol injection (300 mg BID) |
|
| Intervention Group (low-dose group) | Experimental | Androtriol injection (100 mg BID) |
|
| Placebo | Placebo Comparator | Hydroxypropyl-β-cyclodextrin injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shuya Li, MD | Contact | 86-10-59976117 | shuyali85@163.com |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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| 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. |
|
| 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. |
|
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 |
| 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. | Baseline, 14 days or at discharge |
| 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. | 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 | 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. | Baseline, 30 days and 90 days after stroke onset |
| 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. | 36 hours after thrombolysis |
| All-cause mortality | From the time of administration to day 90 |
| Discontinuation of medication due to any reason or adverse events | From the time of administration to day 90 |
| The change of midline shift from baseline at 22-36 hours and 7 days after first treatment | Baseline, 22-36 hours, and 7 days after first treatment |
| The change of lesion volume from baseline at 22-36 hours and 7 days after first treatment | Baseline, 22-36 hours, and 7 days after first treatment |
| The change of edema volume on the lesion side from baseline at 22-36 hours and 7 days after first treatment | Baseline, 22-36 hours, and 7 days after first treatment |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |