Acute Ischemic StrokePhase 3TRACE-LATENCT07201688
Phase III Clinical Trial of rhTNK-tPA in Treating Acute Ischemic Stroke With Extended Time Window.
A Phase 3 study testing rhTNK-tPA in people with Acute Ischemic Stroke, run by CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy of recombinant human tissue-type plasminogen activator variant (rhTNK-tPA) (0.25 mg/kg, maximum dose 25 mg) compared with placebo in patients with acute large vessel occlusive stroke who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- rhTNK-tPA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 890 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 30 Sep 2027
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged ≥ 18 years, regardless of gender;
- Time from symptom onset to treatment is 4.5 - 24 hours(Including the boundary values.), including patients with wake-up stroke or stroke without witnesses; the time of symptom onset is defined as the "last known normal time";
- Modified Rankin Scale (mRS) score ≤ 1 before stroke onset;
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
- Neuroimaging findings: occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA) confirmed by computed tomography angiography (CTA)/magnetic resonance angiography (MRA), which is the responsible vessel for the signs and symptoms of acute ischemic stroke; presence of target mismatch on computed tomography perfusion (CTP) or magnetic resonance imaging (MRI) + magnetic resonance perfusion (MRP) (ischemic core volume < 70 mL, mismatch ratio ≥ 1.8, mismatch volume ≥ 15 mL);
- Voluntary signing of the informed consent form by the participant or their legal guardian.
Who cannot join
- Patients with known allergy to recombinant human tissue plasminogen activator (rhTNK-tPA);
- Patients with an expected life expectancy of less than 1 year;
- Patients with rapidly improving symptoms (which may indicate spontaneous recanalization), as determined by the investigator;
- Patients with a score of > 2 on Item 1a (Level of Consciousness) of the National Institutes of Health Stroke Scale (NIHSS), or those who had a seizure at stroke onset, or had hemiplegia after seizure, or had other neurological/psychiatric disorders that rendered them unable or unwilling to cooperate;
- Severe and persistent hypertension uncontrolled by medication ;
- Blood glucose < 2.8 mmol/L or > 22.2 mmol/L;
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- Active internal bleeding with a high risk of hemorrhage;
- Any known coagulation disorder;
- Known platelet function defect or platelet count less than 100×10⁹/L;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Puyang Oilfield General Hospital
Puyang, Henan, 457001
Yutie Zhao, Chief Physician, 13633935069, 454981103@qq.com
About this study
Official title: Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Recombinant Human TNK Tissue-Type Plasminogen Activator for Injection (rhTNK-tPA, Mingfule) in Intravenous Thrombolysis for Acute Ischemic Stroke With Extended Time Window (4.5-24 Hours After Onset).
This is a multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy of recombinant human tissue-type plasminogen activator variant (rhTNK-tPA) (0.25 mg/kg, maximum dose 25 mg) compared with placebo in patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset. The study plans to enroll patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset (including wake-up strokes and strokes without witnesses). A centralized 1:1 randomization will be adopted, and eligible participants will be randomly assigned to two groups: the experimental group will receive rhTNK-tPA at a dose of 0.25 mg/kg, while the placebo group will receive rhTNK-tPA placebo.
Read the detailed description
This multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aims to evaluate the efficacy of recombinant human tissue-type plasminogen activator variant (rhTNK-tPA) (0.25 mg/kg, maximum dose 25 mg) compared with placebo in patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset. The study initially planned to enroll 890 patients, who would be randomly assigned to the experimental group (rhTNK-tPA group) or the control group (placebo group) at a 1:1 ratio. After an unblinded sample size re-estimation during the interim analysis, the maximum sample size could be adjusted to 1,300 patients.
Key characteristics of the primary study population include: age ≥ 18 years; time from symptom onset to treatment ranging from 4.5 hours to 24 hours; occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by computed tomography angiography (CTA)/magnetic resonance angiography (MRA), which is the responsible vessel for the signs and symptoms of acute ischemic stroke; modified Rankin Scale (mRS) score ≤ 1 before symptom onset; baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6; and presence of target mismatch on computed tomography perfusion (CTP) or magnetic resonance imaging (MRI) combined with magnetic resonance perfusion (MRP) (ischemic core volume < 70 mL, mismatch ratio ≥ 1.8, and mismatch volume ≥ 15 mL). Patients with a known allergy to rhTNK-tPA and those with contraindications to thrombolysis were excluded.
The entire study duration is approximately 90 days, including the screening period, treatment period, and follow-up period. The primary study endpoint is the proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at the 90-day follow-up.
- Conditions
- Acute Ischemic Stroke
- Being tested
- rhTNK-tPA, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rhTNK-tPADrug
Each vial should be dissolved in 3mL of sterile water for injection to prepare a drug solution with a concentration of 5.33mg/mL. Calculate the total drug amount based on the participant's actual body weight, measure the required volume of the drug solution, and ensure the maximum dose does not exceed 25mg. Administer as a single bolus intravenous injection, completing the injection within 5-10 seconds.
PlaceboDrug
One vial is dissolved in 3mL of sterile water for injection. Calculate the total drug amount based on the participant's actual body weight, then measure the required volume of the drug solution. Administer as a single bolus intravenous injection, completing the injection within 5-10 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Receive rhTNK-tPA administration at 0.25mg/kg, with the maximum dose not exceeding 25mg. Receives: Drug: rhTNK-tPA |
| Placebo Group | Placebo comparator | Receive placebo treatment, administration method and dosage same as rhTNK-tPA Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of participants with a score of 0-1 on the modified Rankin Scale (mRS)
The modified Rankin Scale (mRS) is used to assess the status of neurological function recovery in patients after stroke. By evaluating the independence of patients in daily activities, it classifies functional levels into grades 0-6 (Grade 0 indicates no symptoms at all, Grades 1-5 correspond to functional impairments ranging from mild to severe, and Grade 6 indicates death).
Measured: At Day90.
Secondary outcomes (12)
Incidence of symptomatic intracerebral hemorrhage within 36 hours after randomization
Defined by ECASS III: any intraparenchymal or intracranial hemorrhage associated with clinical deterioration, where the latter is defined as an increase of ≥4 points in the National Institutes of Health Stroke Scale [NIHSS] score or death, with confirmation that the hemorrhage is the cause of neurological deterioration.
Measured: 36 Hours after Randomization
Overall mortality rate at Day 90.
The proportion of randomized patients who died within 90 days
Measured: At Day90.
Incidence of significant systemic hemorrhage (moderate to severe per GUSTO classification) at Day 90.
For the Global Use of Strategies to Open Occluded Arteries (GUSTO) Classification, its core lies in categorizing bleeding into three grades-mild, moderate, and severe-based on the impact of bleeding on the patient's clinical status, treatment needs, and prognosis.
Measured: At Day90.
Proportion of adverse events (AEs)/serious adverse events (SAEs) at Day 90.
Adverse Event (AE) refers to any adverse medical event that occurs in a participant after administration of an investigational medicinal product. It may present as signs, symptoms, diseases, or abnormal laboratory findings, but it is not necessarily causally related to the investigational medicinal product. A Serious Adverse Event (SAE) refers to a special safety event among AEs that meets any of the following criteria: "resulting in death, life-threatening, requiring hospitalization/prolongation of existing hospitalization, causing permanent or severe disability/incapacity, leading to congenital anomalies/birth defects, or being another important medical event".
Measured: At Day90.
Modified Rankin Scale (mRS) score at Day 90 (shift analysis).
The modified Rankin Scale (mRS) is used to assess the status of neurological function recovery in patients after stroke. By evaluating the independence of patients in daily activities, it classifies functional levels into grades 0-6 (Grade 0 indicates no symptoms at all, Grades 1-5 correspond to functional impairments ranging from mild to severe, and Grade 6 indicates death).
Measured: At Day90.
Title: Proportion of participants with mRS score of 0-2 at Day 90.
The modified Rankin Scale (mRS) is used to assess the status of neurological function recovery in patients after stroke. By evaluating the independence of patients in daily activities, it classifies functional levels into grades 0-6 (Grade 0 indicates no symptoms at all, Grades 1-5 correspond to functional impairments ranging from mild to severe, and Grade 6 indicates death).
Measured: At Day90.
Proportion of participants with an NIHSS score of ≤1 or a reduction of ≥8 points from baseline within 72 hours after randomization.
The National Institutes of Health Stroke Scale (NIHSS) is a globally accepted tool for assessing the severity of stroke. Primarily used in patients with acute stroke, it evaluates 11 neurological domains including consciousness, gaze, visual fields, facial palsy, limb motor function, sensation, and language. Scores ranging from 0 to 42 are assigned based on the degree of impairment, where a score of 0 indicates normal neurological function and a score of 42 indicates extremely severe impairment.
Measured: 72 Hours after Randomization.
Change in NIHSS score from baseline at Day 7.
The National Institutes of Health Stroke Scale (NIHSS) is a globally accepted tool for assessing the severity of stroke. Primarily used in patients with acute stroke, it evaluates 11 neurological domains including consciousness, gaze, visual fields, facial palsy, limb motor function, sensation, and language. Scores ranging from 0 to 42 are assigned based on the degree of impairment, where a score of 0 indicates normal neurological function and a score of 42 indicates extremely severe impairment.
Measured: At Day7.
Proportion of participants with a Barthel Index (BI) score of ≥95 at Day 90.
The Barthel Index (BI) is a commonly used tool to assess the ability of self-care in daily life for patients with functional impairments (such as those with stroke or spinal cord injury). It mainly evaluates whether patients can independently perform 10 daily activities including eating, dressing, walking, and using the toilet, and assigns a score ranging from 0 to 100 based on their ability level: a score of 100 indicates complete self-care, and the lower the score, the higher the degree of dependence on others.
Measured: At Day90.
Rate of favorable reperfusion (90% improvement in Tmax >6s compared with prior status) within 24 hours after randomization.
The rate of favorable reperfusion is defined as an improvement of 90% or more in the area with Tmax > 6s (compared with the previous status) on imaging examinations.
Measured: 24 Hours after Randomization.
Growth of irreversible cerebral infarction volume before treatment and 24 hours after treatment.
The volume of irreversible cerebral infarction refers to the brain tissue that has suffered irreversible damage after ischemia, and is also called the volume of core infarction.
Measured: 72 Hours after Treatment.
Proportion of participants with favorable reperfusion (TICI 2b/3 or TICI 3) on angiography before endovascular treatment (limited to participants who received endovascular treatment).
The Thrombolysis in Cerebral Infarction (TICI) Scale is a standard for assessing the degree of cerebral vascular recanalization in patients with acute ischemic stroke after endovascular treatment. It evaluates the blood flow recovery of the infarct-related artery via imaging examinations and is mainly categorized into Grades 0 to 3: Grade 0 represents no perfusion, Grade 1 mild perfusion, Grade 2 partial perfusion, and Grade 3 complete perfusion.
Measured: Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start30 Nov 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (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.
- 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
- Model description
- Eligible subjects were centrally randomized at a 1:1 ratio to receive either rhTNK-Tpa or placebo treatment, with the two groups proceeding simultaneously and without mutual interference.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 890 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201688
- Sponsor's protocol ID
- MK02-003
- Acronym
- TRACE-LATE
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Trial of Recombinant Human TNK Tissue-Type Plasminogen Activator for Injection (rhTNK-tPA, Mingfule) in Intravenous Thrombolysis for Acute Ischemic Stroke With Extended Time Window (4.5-24 Hours After Onset).
- ClinicalTrials.gov ID
- NCT07201688
- Acronym / sponsor ID
- TRACE-LATE / MK02-003
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 890 participants (estimated)
- Lead sponsor
- CSPC Mingfule Pharmaceutical (Guangzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 1 Oct 2025 (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 multicenter, randomized, double-blind, placebo-controlled Phase III clinical study designed to evaluate the efficacy of recombinant human tissue-type plasminogen activator variant (rhTNK-tPA) (0.25 mg/kg, maximum dose 25 mg) compared with placebo in patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset. The study plans to enroll patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset (including wake-up strokes and strokes without witnesses). A centralized 1:1 randomization will be adopted, and eligible participants will be randomly assigned to two groups: the experimental group will receive rhTNK-tPA at a dose of 0.25 mg/kg, while the placebo group will receive rhTNK-tPA placebo.
Detailed description
This multicenter, randomized, double-blind, placebo-controlled Phase III clinical study aims to evaluate the efficacy of recombinant human tissue-type plasminogen activator variant (rhTNK-tPA) (0.25 mg/kg, maximum dose 25 mg) compared with placebo in patients with acute large vessel occlusive stroke who present within 4.5 to 24 hours of symptom onset. The study initially planned to enroll 890 patients, who would be randomly assigned to the experimental group (rhTNK-tPA group) or the control group (placebo group) at a 1:1 ratio. After an unblinded sample size re-estimation during the interim analysis, the maximum sample size could be adjusted to 1,300 patients.
Key characteristics of the primary study population include: age ≥ 18 years; time from symptom onset to treatment ranging from 4.5 hours to 24 hours; occlusion of the internal carotid artery, M1 or M2 segment of the middle cerebral artery confirmed by computed tomography angiography (CTA)/magnetic resonance angiography (MRA), which is the responsible vessel for the signs and symptoms of acute ischemic stroke; modified Rankin Scale (mRS) score ≤ 1 before symptom onset; baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6; and presence of target mismatch on computed tomography perfusion (CTP) or magnetic resonance imaging (MRI) combined with magnetic resonance perfusion (MRP) (ischemic core volume < 70 mL, mismatch ratio ≥ 1.8, and mismatch volume ≥ 15 mL). Patients with a known allergy to rhTNK-tPA and those with contraindications to thrombolysis were excluded.
The entire study duration is approximately 90 days, including the screening period, treatment period, and follow-up period. The primary study endpoint is the proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at the 90-day follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible subjects were centrally randomized at a 1:1 ratio to receive either rhTNK-Tpa or placebo treatment, with the two groups proceeding simultaneously and without mutual interference.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Drug: rhTNK-tPAReceive rhTNK-tPA administration at 0.25mg/kg, with the maximum dose not exceeding 25mg. |
| Placebo Group | Placebo comparator | Drug: PlaceboReceive placebo treatment, administration method and dosage same as rhTNK-tPA |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 18 years, regardless of gender;
- Time from symptom onset to treatment is 4.5 - 24 hours(Including the boundary values.), including patients with wake-up stroke or stroke without witnesses; the time of symptom onset is defined as the "last known normal time";
- Modified Rankin Scale (mRS) score ≤ 1 before stroke onset;
- Baseline National Institutes of Health Stroke Scale (NIHSS) score ≥ 6;
- Neuroimaging findings: occlusion of the internal carotid artery (ICA), M1 or M2 segment of the middle cerebral artery (MCA) confirmed by computed tomography angiography (CTA)/magnetic resonance angiography (MRA), which is the responsible vessel for the signs and symptoms of acute ischemic stroke; presence of target mismatch on computed tomography perfusion (CTP) or magnetic resonance imaging (MRI) + magnetic resonance perfusion (MRP) (ischemic core volume < 70 mL, mismatch ratio ≥ 1.8, mismatch volume ≥ 15 mL);
Key exclusion criteria (9 listed)
- Patients with known allergy to recombinant human tissue plasminogen activator (rhTNK-tPA);
- Patients with an expected life expectancy of less than 1 year;
- Patients with rapidly improving symptoms (which may indicate spontaneous recanalization), as determined by the investigator;
- Patients with a score of > 2 on Item 1a (Level of Consciousness) of the National Institutes of Health Stroke Scale (NIHSS), or those who had a seizure at stroke onset, or had hemiplegia after seizure, or had other neurological/psychiatric disorders that rendered them unable or unwilling to cooperate;
- Severe and persistent hypertension uncontrolled by medication ;
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 |
|---|---|---|
| rhTNK-tPAEach vial should be dissolved in 3mL of sterile water for injection to prepare a drug solution with a concentration of 5.33mg/mL. Calculate the total drug amount based on the participant's actual body weight, measure the required volume of the drug solution, and ensure the maximum dose does not exceed 25mg. Administer as a single bolus intravenous injection, completing the injection within 5-10 seconds. | Drug | Experimental Group |
| PlaceboOne vial is dissolved in 3mL of sterile water for injection. Calculate the total drug amount based on the participant's actual body weight, then measure the required volume of the drug solution. Administer as a single bolus intravenous injection, completing the injection within 5-10 seconds. | Drug | Placebo Group |
Primary outcome
The proportion of participants with a score of 0-1 on the modified Rankin Scale (mRS)
Time frame: At Day90.
The modified Rankin Scale (mRS) is used to assess the status of neurological function recovery in patients after stroke. By evaluating the independence of patients in daily activities, it classifies functional levels into grades 0-6 (Grade 0 indicates no symptoms at all, Grades 1-5 correspond to functional impairments ranging from mild to severe, and Grade 6 indicates death).
12 secondary outcomes
Incidence of symptomatic intracerebral hemorrhage within 36 hours after randomization
Time frame: 36 Hours after Randomization
Overall mortality rate at Day 90.
Time frame: At Day90.
Incidence of significant systemic hemorrhage (moderate to severe per GUSTO classification) at Day 90.
Time frame: At Day90.
Proportion of adverse events (AEs)/serious adverse events (SAEs) at Day 90.
Time frame: At Day90.
Modified Rankin Scale (mRS) score at Day 90 (shift analysis).
Time frame: At Day90.
Title: Proportion of participants with mRS score of 0-2 at Day 90.
Time frame: At Day90.
Proportion of participants with an NIHSS score of ≤1 or a reduction of ≥8 points from baseline within 72 hours after randomization.
Time frame: 72 Hours after Randomization.
Change in NIHSS score from baseline at Day 7.
Time frame: At Day7.
Proportion of participants with a Barthel Index (BI) score of ≥95 at Day 90.
Time frame: At Day90.
Rate of favorable reperfusion (90% improvement in Tmax >6s compared with prior status) within 24 hours after randomization.
Time frame: 24 Hours after Randomization.
Growth of irreversible cerebral infarction volume before treatment and 24 hours after treatment.
Time frame: 72 Hours after Treatment.
Proportion of participants with favorable reperfusion (TICI 2b/3 or TICI 3) on angiography before endovascular treatment (limited to participants who received endovascular treatment).
Time frame: Periprocedural
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 16 Dec 2025.
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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.
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 rhTNK-tPA in people with Acute Ischemic Stroke, run by CSPC Mingfule Pharmaceutical (Guangzhou) 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 6 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 16 Dec 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?
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 Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), 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 score of 0-1 on the modified Rankin Scale (mRS) (time frame: At Day90.). 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 16 Dec 2025.