Acute Ischemic StrokePhase 3NCT06648304
Evaluate the Efficacy and Safety of TTYP01 Tablets in the Treatment of Acute Ischemic Stroke
A Phase 3 study testing TTYP01 tablets in people with Acute Ischemic Stroke, run by Shanghai Auzone Biological Technology Co., Ltd. at 1 site in China.
Trial summary
The study is designed as a multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy and safety of TTYP01 tablets in the treatment of 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?
- TTYP01 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 614 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2023to 17 Jun 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Subjects eligible for enrollment in the study must meet all of the following inclusion criteria:
- Patients aged 18 ~ 80 years (both inclusive);
- Patients diagnosed with acute ischemic stroke according to the 2019AHA/ASA guidelines for ischemic stroke;
- Patients who do not accept suggestions of thrombolysis or thrombectomy or who do not meet the indications for these treatments;
- Patients with symptom onset within ≤ 24 hours; for wake-up strokes or when the exact time of symptom onset cannot be determined due to aphasia or disturbance of consciousness, the last time the patient is seen to be normal shall prevail;
- Patients who are having their first stroke or those who are experiencing a recurrence of stoke after a good recovery (mRS score of 0-1) from their most recent stroke;
- There are clear signs of neurological deficit: 6≤NIHSS score≤20, and also, the sum of NIHSS score for the 5th upper limb and the 6th lower limb is greater than or equal to 2.
- Subjects or their guardians are informed about the study, voluntarily agree to the participation, and provide written informed consent.
Who cannot join
- Subjects who meet any of the following criteria will be excluded from the study:
- Patients with any contraindications (such as metal implants like cardiac pacemakers, claustrophobia, etc.) that prevent them from undergoing CT or MRI examinations;
- Cranial CT or MRI confirmed intracranial hemorrhagic conditions, including but not limited to cerebral hemorrhage, epidural hematoma, subdural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, and traumatic cerebral hemorrhage; or cases of cerebral infarction with post-infarction hemorrhagic transformation. In cases of minor oozing, the investigator will determine eligibility for enrollment;
- Patients with massive cerebral infarction (low density > 1/3 of the cerebral hemisphere) as indicated by imaging examinations such as CT or MRI;
- Patients with cerebral infarction accompanied by disturbance of consciousness (NIHSS score Ia > 1 point), posterior circulation infarction, or transient ischemic attack (TIA);
- Patients with severe mental disorders, depression, or comorbid conditions affecting cognitive function, such as Alzheimer's disease, Parkinson's dementia, or Lewy body dementia, making them unable or unwilling to cooperate with the study;
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- Patients who are scheduled for or have received intravenous thrombolysis, or who require endovascular treatment in the immediate or recent future (within 90 days);
- Patients with a history of brain malignant tumors or brain parasitic diseases;
- Patients with a history of severe craniocerebral injury or intracranial infection and an mRS score > 1 prior to this episode;
- Patients with severe hypertension (systolic blood pressure ≥ 220 mmHg or diastolic blood pressure ≥ 120 mmHg) that is uncontrolled by treatment before the first dose;
- Patients with blood glucose levels below 2.7 mmol/L without correction or above 22.2 mmol/L at the time of admission;
- Patients with dysphagia;
- Patients with a history of rheumatic heart disease or atrial fibrillation; those with a heart rate of less than 40 beats per minute or greater than 120 beats per minute; patients with second or third-degree heart block without a pacemaker or other malignant arrhythmias; and patients who have experienced acute myocardial infarction, cardiac intervention, or heart failure within the past 6 months (classified by the New York Heart Association [NYHA] as III-IV).
- Patients with other serious systemic or organ diseases that the investigators believe may hinder the evaluation of efficacy or make it unlikely for the patient to complete the expected course of treatment and follow-up (such as malignant tumors with a life expectancy of less than 3 months, etc.).;
- Patients with severe liver and kidney diseases or abnormal renal and liver function tests (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] ≥ 3.0 times the upper limit of normal [ULN]; serum creatinine [Cr] > 2.0 times the ULN);
- Patients with a bleeding tendency, including platelet count (PLT) less than 75.0×10^9/L, or severe bleeding within the 3 months prior to the onset of the disease.
- Patients with contraindications to antiplatelet therapy or statin therapy;
- Patients with allergic constitution, hypersensitivity to Edaravone or its excipients;
- Patients with suspected or confirmed history of alcohol or drug abuse;
- Patients who are pregnant, lactating or have a recent pregnancy plan and are unwilling to use contraception;
- Patients who have participated in other clinical trials within 3 months or are participating in other clinical studies prior to this study;
- Patients who are deemed unsuitable by the investigator for participation in the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TTYP01 Tablets in the Treatment of Acute Ischemic Stroke
The study is designed as a multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy and safety of TTYP01 tablets in the treatment of acute ischemic stroke.
Read the detailed description
A multicenter, randomized, double-blind, parallel, placebo-controlled trial design is used to evaluate the efficacy and safety of TTYP01 tablets in the treatment of patients with acute ischemic stroke.
It is estimated that 618 patients will be enrolled and randomly assigned to the treatment group and the placebo control group in a 1:1 ratio, with 309 patients in each group. Normally, the duration of this study is approximately 90 days. This study will be divided into 2 periods, with a total of five visits: Treatment observation period: D1 ~ D28 (the minimum length of in-hospital observation will be not less than 7 days), including 3 visits (V1- V3); follow-up period: D29 ~ D90, including 2 visits (V4: D60 ± 5 for telephone follow-up; V5: D90 ± 5, returning to hospital for end-of-study visit).
- Conditions
- Acute Ischemic Stroke
- Being tested
- TTYP01 tablets, Placebo (Simulant TTYP01 Tablets)
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTYP01 tabletsDrug
Administered 30~60 minutes before breakfast and dinner (i.e., fasting state), bid. Subjects are given 2 tablets (60 mg) of investigational drug each time. The first administration should be administered within 1 hour after enrollment. If the subject is randomized in a fed state, the first administration may be administered in a non-fasting state. The interval between the first and second administration should be at least 6 hours, with continuous administration for 28 days (56 administrations).
Placebo (Simulant TTYP01 Tablets)Drug
Administered 30~60 minutes before breakfast and dinner (i.e., fasting state), bid. Subjects are given 2 tablets (0 mg) of placebo each time. The first administration should be administered within 1 hour after enrollment. If the subject is randomized in a fed state, the first administration may be administered in a non-fasting state. The interval between the first and second administration should be at least 6 hours, with continuous administration for 28 days (56 administrations).
| Study group | Role | What they receive |
|---|---|---|
| TTYP01 tablets | Experimental | 2 tablets (60 mg) of TTYP01, twice daily, administered 30~60 minutes before breakfast and dinner Receives: Drug: TTYP01 tablets |
| Placebo (Simulant TTYP01 Tablets) | Placebo comparator | 2 tablets (0 mg) of placebo, twice daily, administered 30~60 minutes before breakfast and dinner Receives: Drug: Placebo (Simulant TTYP01 Tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with mRS score ≤1 on Day 90 of treatment.
The mRS (modified Rankin Scale) is a scoring system used to assess the ability of post-stroke patients in their daily lives. It assesses the degree of functional impairment of patients after stroke through a standardized questionnaire, and is one of the most widely used tools for assessing the sequelae of stroke internationally. The MRS scores range from 0 to 5, with higher scores indicating more severe disability in patients.
Measured: 90 days after treatment initiation
Secondary outcomes (13)
mRS score on Day 90 of treatment
The mRS (modified Rankin Scale) is a scoring system used to assess the ability of post-stroke patients in their daily lives. It assesses the degree of functional impairment of patients after stroke through a standardized questionnaire, and is one of the most widely used tools for assessing the sequelae of stroke internationally. The MRS scores range from 0 to 5, with higher scores indicating more severe disability in patients.
Measured: 90 days after treatment initiation
Proportion of subjects with mRS score ≤2 on D90 of treatment
The mRS (modified Rankin Scale) is a scoring system used to assess the ability of post-stroke patients in their daily lives. It assesses the degree of functional impairment of patients after stroke through a standardized questionnaire, and is one of the most widely used tools for assessing the sequelae of stroke internationally. The MRS scores range from 0 to 5, with higher scores indicating more severe disability in patients.
Measured: 90 days after treatment initiation
Change from baseline in mRS score on D7, D28, D60 and D90 of treatment
The mRS (modified Rankin Scale) is a scoring system used to assess the ability of post-stroke patients in their daily lives. It assesses the degree of functional impairment of patients after stroke through a standardized questionnaire, and is one of the most widely used tools for assessing the sequelae of stroke internationally. The MRS scores range from 0 to 5, with higher scores indicating more severe disability in patients.
Measured: Baseline and 7, 28, 60, 90 days after treatment initiation
Change in NIHSS score from baseline on D7, D28 and D90 of treatment
The NIHSS (National Institutes of Health Stroke Scale) is a standardized neurological examination tool used to assess neurological deficits in stroke patients. The scale consists of 15 tests and the total score is the sum of the individual scores ranges from 0 to 42, with lower scores indicating a better state of the patient.
Measured: Baseline and 7, 28, 90 days after treatment initiation
Proportion of patients with NIHSS score improvement ≥ 4 points on D7, D28, and D90 of treatment
The NIHSS (National Institutes of Health Stroke Scale) is a standardized neurological examination tool used to assess neurological deficits in stroke patients. The scale consists of 15 tests and the total score is the sum of the individual scores ranges from 0 to 42, with lower scores indicating a better state of the patient.
Measured: 7, 28 and 90 days after treatment initiation
Proportion of subjects with NIHSS score of 0-1 on D7, D28 and D90 of treatment
The NIHSS (National Institutes of Health Stroke Scale) is a standardized neurological examination tool used to assess neurological deficits in stroke patients. The scale consists of 15 tests and the total score is the sum of the individual scores ranges from 0 to 42, with lower scores indicating a better state of the patient.
Measured: 7, 28 and 90 days after treatment initiation
Change in BI score from baseline on D7, D28 and D90 of treatment
The BI (Barthel Index) is used to assess the patient's ability to perform activities of daily living and can be used to evaluate the patient's functional recovery before and after treatment, and it is one of the most widely used and researched methods of basic assessment of activities of daily living in clinical practice, with credible results. It is mainly based on the patient's actual daily performance and is not judged by the ability the patient may have. The BI scores range from 0 to 100, with higher scores indicating a better state of the patient.
Measured: Baseline and 7, 28, 90 days after treatment initiation
Proportion of subjects with BI score ≥ 95 points on D7, D28 and D90 of treatment
The BI (Barthel Index) is used to assess the patient's ability to perform activities of daily living and can be used to evaluate the patient's functional recovery before and after treatment, and it is one of the most widely used and researched methods of basic assessment of activities of daily living in clinical practice, with credible results. It is mainly based on the patient's actual daily performance and is not judged by the ability the patient may have. The BI scores range from 0 to 100, with higher scores indicating a better state of the patient.
Measured: 7, 28 and 90 days after treatment initiation
MoCA score and comparison on D7, D28 and D90 of treatment
The MoCA (Montreal Cognitive Assessment) Scale is a rating tool used to provide rapid screening for cognitive dysfunction. It includes 11 screening items in 8 cognitive domains: attention and concentration, executive function, memory, language, visual structural skills, abstract thinking, calculation and orientation. The total score is 30, with ≥26 being normal; the lower the score, the more severe the cognitive impairment.
Measured: 7, 28 and 90 days after treatment initiation
HDRS score and comparison on D7, D28 and D90 of treatment
The HDRS (Hamilton Depression Scale) was developed by Hamilton in 1960 and is the most commonly used scale for assessing depressive states in clinical settings. There are three versions of this scale: 17-item, 21-item and 24-item. The 21-item version was used for this Clinical Study, with a score range from 0 to 64. A score greater than 30 is severe depression, greater than 20 is moderate depression, and greater than 17 is mild depression.
Measured: 7, 28 and 90 days after treatment initiation
Proportion of subjects with recurrent stroke within 90 days of treatment
Measured: within 90 days of treatment
Changes in cranial MRI findings (infarct volume) relative to baseline
Infarct volume will report in mm^3
Measured: Baseline and 5, 28 days after treatment initiation
Changes in cranial MRI findings (infarct area) relative to baseline
Infarct area will report in mm^2
Measured: Baseline and 5, 28 days after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start25 Apr 2023
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Auzone Biological Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yan-Jiang Wang, MD & PhD, Principal investigator, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648304
- Sponsor's protocol ID
- TTYP01-III-AIS
- Status last verified
- Jan 2025
- First submitted
- 15 Oct 2024
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xiang Y, Jin WS, Zhu XC, Song Y, Chen X, Wang QH, Sun HL, Zhao Y, Yu XR, Feng T, Guo AH, Dai HG, Huang HN, Fang JX, Wang MH, Peng YM, Liu XM, Bu XL, Liu YH, Zhang M, Anderson CS, Nogueira RG, He WL, Zhou XF, Wang YJ; ERASE-STROKE investigators. Early and prolonged oral edaravone for neuroprotection in acute ischemic stroke: the ERASE-STROKE randomized controlled phase 3 trial. Sci Bull (Beijing). 2026 Aug 22:S2095-9273(26)00928-X. doi: 10.1016/j.scib.2026.08.038. Online ahead of print.
PubMed 42705987
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of TTYP01 Tablets in the Treatment of Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT06648304
- Acronym / sponsor ID
- TTYP01-III-AIS
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- Shanghai Auzone Biological Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 18 Oct 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.
The study is designed as a multi-center, randomized, double-blind, parallel, placebo-controlled trial to evaluate the efficacy and safety of TTYP01 tablets in the treatment of acute ischemic stroke.
Detailed description
A multicenter, randomized, double-blind, parallel, placebo-controlled trial design is used to evaluate the efficacy and safety of TTYP01 tablets in the treatment of patients with acute ischemic stroke.
It is estimated that 618 patients will be enrolled and randomly assigned to the treatment group and the placebo control group in a 1:1 ratio, with 309 patients in each group. Normally, the duration of this study is approximately 90 days. This study will be divided into 2 periods, with a total of five visits: Treatment observation period: D1 ~ D28 (the minimum length of in-hospital observation will be not less than 7 days), including 3 visits (V1- V3); follow-up period: D29 ~ D90, including 2 visits (V4: D60 ± 5 for telephone follow-up; V5: D90 ± 5, returning to hospital for end-of-study visit).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TTYP01 tablets | Experimental | Drug: TTYP01 tablets2 tablets (60 mg) of TTYP01, twice daily, administered 30~60 minutes before breakfast and dinner |
| Placebo (Simulant TTYP01 Tablets) | Placebo comparator | Drug: Placebo (Simulant TTYP01 Tablets)2 tablets (0 mg) of placebo, twice daily, administered 30~60 minutes before breakfast and dinner |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects eligible for enrollment in the study must meet all of the following inclusion criteria:
- Patients aged 18 ~ 80 years (both inclusive);
- Patients diagnosed with acute ischemic stroke according to the 2019AHA/ASA guidelines for ischemic stroke;
- Patients who do not accept suggestions of thrombolysis or thrombectomy or who do not meet the indications for these treatments;
- Patients with symptom onset within ≤ 24 hours; for wake-up strokes or when the exact time of symptom onset cannot be determined due to aphasia or disturbance of consciousness, the last time the patient is seen to be normal shall prevail;
Key exclusion criteria (22 listed)
- Patients with any contraindications (such as metal implants like cardiac pacemakers, claustrophobia, etc.) that prevent them from undergoing CT or MRI examinations;
- Cranial CT or MRI confirmed intracranial hemorrhagic conditions, including but not limited to cerebral hemorrhage, epidural hematoma, subdural hematoma, intracranial hematoma, ventricular hemorrhage, subarachnoid hemorrhage, and traumatic cerebral hemorrhage; or cases of cerebral infarction with post-infarction hemorrhagic transformation. In cases of minor oozing, the investigator will determine eligibility for enrollment;
- Patients with massive cerebral infarction (low density > 1/3 of the cerebral hemisphere) as indicated by imaging examinations such as CT or MRI;
- Patients with cerebral infarction accompanied by disturbance of consciousness (NIHSS score Ia > 1 point), posterior circulation infarction, or transient ischemic attack (TIA);
- Patients with severe mental disorders, depression, or comorbid conditions affecting cognitive function, such as Alzheimer's disease, Parkinson's dementia, or Lewy body dementia, making them unable or unwilling to cooperate with the study;
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 |
|---|---|---|
| TTYP01 tabletsAdministered 30~60 minutes before breakfast and dinner (i.e., fasting state), bid. Subjects are given 2 tablets (60 mg) of investigational drug each time. The first administration should be administered within 1 hour after enrollment. If the subject is randomized in a fed state, the first administration may be administered in a non-fasting state. The interval between the first and second administration should be at least 6 hours, with continuous administration for 28 days (56 administrations). | Drug | TTYP01 tablets |
| Placebo (Simulant TTYP01 Tablets)Administered 30~60 minutes before breakfast and dinner (i.e., fasting state), bid. Subjects are given 2 tablets (0 mg) of placebo each time. The first administration should be administered within 1 hour after enrollment. If the subject is randomized in a fed state, the first administration may be administered in a non-fasting state. The interval between the first and second administration should be at least 6 hours, with continuous administration for 28 days (56 administrations). | Drug | Placebo (Simulant TTYP01 Tablets) |
Primary outcome
Proportion of subjects with mRS score ≤1 on Day 90 of treatment.
Time frame: 90 days after treatment initiation
The mRS (modified Rankin Scale) is a scoring system used to assess the ability of post-stroke patients in their daily lives. It assesses the degree of functional impairment of patients after stroke through a standardized questionnaire, and is one of the most widely used tools for assessing the sequelae of stroke internationally. The MRS scores range from 0 to 5, with higher scores indicating more severe disability in patients.
13 secondary outcomes
mRS score on Day 90 of treatment
Time frame: 90 days after treatment initiation
Proportion of subjects with mRS score ≤2 on D90 of treatment
Time frame: 90 days after treatment initiation
Change from baseline in mRS score on D7, D28, D60 and D90 of treatment
Time frame: Baseline and 7, 28, 60, 90 days after treatment initiation
Change in NIHSS score from baseline on D7, D28 and D90 of treatment
Time frame: Baseline and 7, 28, 90 days after treatment initiation
Proportion of patients with NIHSS score improvement ≥ 4 points on D7, D28, and D90 of treatment
Time frame: 7, 28 and 90 days after treatment initiation
Proportion of subjects with NIHSS score of 0-1 on D7, D28 and D90 of treatment
Time frame: 7, 28 and 90 days after treatment initiation
Change in BI score from baseline on D7, D28 and D90 of treatment
Time frame: Baseline and 7, 28, 90 days after treatment initiation
Proportion of subjects with BI score ≥ 95 points on D7, D28 and D90 of treatment
Time frame: 7, 28 and 90 days after treatment initiation
MoCA score and comparison on D7, D28 and D90 of treatment
Time frame: 7, 28 and 90 days after treatment initiation
HDRS score and comparison on D7, D28 and D90 of treatment
Time frame: 7, 28 and 90 days after treatment initiation
Proportion of subjects with recurrent stroke within 90 days of treatment
Time frame: within 90 days of treatment
Changes in cranial MRI findings (infarct volume) relative to baseline
Time frame: Baseline and 5, 28 days after treatment initiation
Changes in cranial MRI findings (infarct area) relative to baseline
Time frame: Baseline and 5, 28 days after treatment initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Derived from this study: PubMed 42705987Xiang Y, Jin WS, Zhu XC, Song Y, Chen X, Wang QH, Sun HL, Zhao Y, Yu XR, Feng T, Guo AH, Dai HG, Huang HN, Fang JX, Wang MH, Peng YM, Liu XM, Bu XL, Liu YH, Zhang M, Anderson CS, Nogueira RG, He WL, Zhou XF, Wang YJ; ERASE-STROKE investigators. Early and prolonged oral edaravone for neuroprotection in acute ischemic stroke: the ERASE-STROKE randomized controlled phase 3 trial. Sci Bull (Beijing). 2026 Aug 22:S2095-9273(26)00928-X. doi: 10.1016/j.scib.2026.08.038. Online ahead of print.
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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. This study is not recruiting at the moment.
Yan-Jiang Wang, MD & PhD principal investigator
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TTYP01 tablets in people with Acute Ischemic Stroke, run by Shanghai Auzone Biological Technology Co., Ltd. at 1 site in China.
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 8 inclusion and 22 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: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with mRS score ≤1 on Day 90 of treatment. (time frame: 90 days after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06648304, which also lists 1 linked publication.
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 3 Feb 2025.