Acute Ischemic StrokePhase 2NCT06679322
The Androtriol Injection for the Treatment of Acute Ischemic Stroke
A Phase 2 study testing Androtriol Injection (High-dose group), Androtriol Injection (Low-dose group) and Hydroxypropyl-β-cyclodextrin injection in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Androtriol Injection (High-dose group), Androtriol Injection (Low-dose group) and Hydroxypropyl-β-cyclodextrin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2024to 30 Oct 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Trial of Androtriol Injection for the Treatment of Acute Ischemic Stroke
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
- Being tested
- Androtriol Injection (High-dose group), Androtriol Injection (Low-dose group), Hydroxypropyl-β-cyclodextrin injection
- Keywords
- Androtriol, Acute Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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 injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (high-dose group) | Experimental | Androtriol injection (300 mg BID) Receives: Drug: Androtriol Injection (High-dose group) |
| Intervention Group (low-dose group) | Experimental | Androtriol injection (100 mg BID) Receives: Drug: Androtriol Injection (Low-dose group) |
| Placebo | Placebo comparator | Hydroxypropyl-β-cyclodextrin injection Receives: Drug: Hydroxypropyl-β-cyclodextrin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 90 days after stroke onset
Secondary outcomes (5)
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).
Measured: 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
The mRS denotes modified Rankin Scale, ranging from 0 (no neurologic deficit, no symptoms or completely recovered) to 6 (death).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 30 days and 90 days after stroke onset
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start31 Oct 2024 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679322
- Sponsor's protocol ID
- YC-6-PIIb-AIS
- Status last verified
- Nov 2024
- First submitted
- 29 Oct 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase IIb Clinical Trial of Androtriol Injection for the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06679322
- Acronym / sponsor ID
- YC-6-PIIb-AIS
- Conditions
- Acute Ischemic Stroke
- Keywords
- Androtriol, Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Study start
- 31 Oct 2024 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (high-dose group) | Experimental | Drug: Androtriol Injection (High-dose group)Androtriol injection (300 mg BID) |
| Intervention Group (low-dose group) | Experimental | Drug: Androtriol Injection (Low-dose group)Androtriol injection (100 mg BID) |
| Placebo | Placebo comparator | Drug: Hydroxypropyl-β-cyclodextrin injectionHydroxypropyl-β-cyclodextrin injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Intervention Group (high-dose group) |
| 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. | Drug | Intervention Group (low-dose group) |
| Hydroxypropyl-β-cyclodextrin injectionParticipants 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. | Drug | Placebo |
Primary outcome
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).
5 secondary outcomes
The modified Rankin Scale (mRS) scores at 90 days after stroke
Time frame: 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
Time frame: 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
Time frame: Baseline, 14 days or at discharge
The change of Barthel Index (BI) scores at 30 days and 90 days after stroke onset
Time frame: 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
Time frame: Baseline, 30 days and 90 days after stroke onset
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Androtriol Injection (High-dose group), Androtriol Injection (Low-dose group) and Hydroxypropyl-β-cyclodextrin injection in people with Acute Ischemic Stroke, run by Beijing Tiantan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shuya Li, MD (86-10-59976117, shuyali85@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.