Aneurysmal Subarachnoid Hemorrhage (aSAH)Phase 4aSAH-ASANCT07642427
Early Prophylactic Aspirin for Aneurysmal Subarachnoid Hemorrhage
A Phase 4 study testing Aspirin in people with Aneurysmal Subarachnoid Hemorrhage (aSAH) and Delayed Cerebral Ischemia, run by Ganzhou City People's Hospital at 1 site in China.
Trial summary
This study is a multicenter, prospective, double-blind, randomized controlled trial designed to evaluate whether early prophylactic use of aspirin improves functional outcomes in patients with aneurysmal subarachnoid hemorrhage (aSAH). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage (aSAH), Delayed Cerebral Ischemia
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 388 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2026to Aug 2029
- Phase
- Phase 4
- 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 years and ≤ 80 years.
- Spontaneous subarachnoid hemorrhage (SAH) confirmed by non-contrast head CT.
- Diagnosis of ruptured intracranial aneurysm confirmed, and successfully treated by either surgical clipping or endovascular coiling within 48 hours of ictus.
- Hunt-Hess grade ≤ 4 or WFNS grade ≤ 4 (assessed within 48 hours of SAH onset).
- Fisher grade 2-4 or modified Fisher grade 1-4.
- No significant focal neurological deficit after aneurysm intervention, defined as NIHSS scores ≤ 1 in the following items: 5a (left arm motor), 5b (right arm motor), 6a (left leg motor), 6b (right leg motor), and 9 (language).
- Pre-morbid modified Rankin Scale (mRS) score ≤ 1 prior to SAH onset.
Who cannot join
- Hunt-Hess grade 5 or WFNS grade 5 (assessed within 48 hours of SAH onset).
- Patients requiring any intracranial stent or non-embolic intrasaccular device during aneurysm embolization, with post-procedural need for antiplatelet therapy.
- Angiogram-negative SAH.
- Note: Prior history of ruptured intracranial aneurysm or re-rupture of previously treated aneurysm is not excluded.
- Moderate-to-severe vasospasm demonstrated on pre-operative or intra-operative CTA/DSA in the emergency setting.
- SAH caused by non-saccular aneurysms, including mycotic, blood-blister, fusiform, or dissecting aneurysms, or cases without basal cistern subarachnoid hemorrhage.
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- Significant pre-existing intracranial pathology at the time of enrollment, including but not limited to: traumatic brain injury, moyamoya disease, high suspicion or documented CNS vasculitis, severe fibromuscular dysplasia, arteriovenous malformation, arteriovenous fistula, significant cervical or intracranial atherosclerotic stenosis (≥70%), or malignant brain tumor.
- Medical conditions requiring chronic use of antiplatelet agents (aspirin, clopidogrel, or ticagrelor), such as transient ischemic attack, myocardial infarction, atrial fibrillation, prosthetic heart valve, arteriovenous fistula, unstable angina, or other conditions requiring thromboprophylaxis.
- Thrombocytopenia (platelet count <20,000/μL, excluding aggregation artifacts), active disseminated intravascular coagulation (DIC) at enrollment, or documented history of coagulopathy or bleeding diathesis.
- History of gastrointestinal bleeding or major systemic hemorrhage within 30 days, hemoglobin <8 g/dL at admission, INR ≥1.5, or severe hepatic impairment defined as AST, ALT, alkaline phosphatase (AP), or GGT >2 times the upper limit of normal.
- Creatinine clearance <30 mL/min.
- Severe comorbidities that may confound study outcomes, including but not limited to: multiple sclerosis, dementia, major depression, immunosuppressed state or during intensive immunosuppressive therapy, cancer with expected survival <1 year, multi-organ failure, or any other condition potentially causing cognitive impairment.
- Contraindications to aspirin therapy, including:
- Hypersensitivity to aspirin, other salicylates, or any excipients in the formulation;
- History of asthma induced by salicylates or NSAIDs;
- Active peptic ulcer disease;
- Bleeding diathesis;
- Hepatic or renal failure;
- Uncontrolled severe heart failure;
- Concomitant use with methotrexate at doses ≥15 mg/week.
- Pregnancy or positive HCG test.
- Incomplete repair of the responsible aneurysm as judged by the treating physician, with high risk of early re-bleeding.
- History of head trauma within 3 months prior to SAH onset.
- Recent cerebral disease within 3 months prior to SAH onset, such as tumor, stroke, epilepsy, vasculitis, AVM, or hydrocephalus.
- History of psychiatric illness or seizure disorder.
- Breastfeeding women.
- Expected survival <1 year prior to SAH onset.
- Participation in another randomized clinical trial that may confound the evaluation of this study.
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
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341000
Qiuhuang Jiang, MD, PhD, +8613607979100, jiangqh1968@126.com
Xinyun Ye, MD, PhD, +8615979789987, yexinyun1270@163.com
About this study
Official title: Study on the Efficacy and Safety of Early Prophylactic Use of Aspirin in Improving Prognosis of Patients With Aneurysmal Subarachnoid Hemorrhage: A Multicenter, Prospective, Double-Blind, Randomized Controlled Trial
This study is a multicenter, prospective, double-blind, randomized controlled trial designed to evaluate whether early prophylactic use of aspirin improves functional outcomes in patients with aneurysmal subarachnoid hemorrhage (aSAH). Patients with aSAH who have undergone successful aneurysm securing will be randomly assigned to receive either aspirin plus standard care or a placebo plus standard care. The study drug will be started within 48 hours of undergone successful aneurysm securing and continued for not less than 10 days and not more than 14 consecutive days. The main goal is to compare the rate of favorable functional outcomes at 3 months between the two groups. Secondary goals include evaluating the incidence of delayed cerebral ischemia, cerebral infarction, mortality, and safety outcomes such as major bleeding events.
Read the detailed description
Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening neurological emergency associated with high rates of morbidity and mortality. Delayed cerebral ischemia (DCI) and subsequent cerebral infarction are major contributors to poor functional outcomes in survivors. Antiplatelet agents such as aspirin have been hypothesized to reduce the risk of microthrombosis and DCI, but evidence for their early prophylactic use in aSAH remains limited and controversial. This trial aims to investigate the efficacy and safety of early aspirin administration in improving long-term functional outcomes in aSAH patients. Eligible patients will be randomized into two groups: the intervention group will receive 100 mg of oral aspirin daily for not less than 10 days and not more than 14 consecutive days, while the control group will receive an identical placebo. All patients in both groups will receive standardized aSAH management according to current clinical guidelines, including nimodipine, blood pressure control, and supportive care. The primary endpoint is the functional outcome measured by the modified Rankin Scale (mRS) at 3 months. Secondary endpoints include incidence of clinical DCI at discharge, percentage of imaging DCI detected on CT/MRI at discharge, all-cause mortality at 3 months, and safety outcomes including major bleeding events.
- Being tested
- Aspirin, Placebo
- Keywords
- Aneurysmal subarachnoid hemorrhage, Aspirin, Delayed cerebral ischemia, Antiplatelet therapy, Functional outcome, Randomized controlled trial
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Aspirin 100 mg (1 tablet) administered orally, via nasogastric tube, or rectally within 48 hours after aneurysm embolization or surgical clipping, once daily, for a minimum of 10 consecutive days and a maximum of 14 consecutive days.
PlaceboDrug
Placebo 1 tablet (identical in appearance to aspirin 100 mg) administered orally, via nasogastric tube, or rectally within 48 hours after aneurysm embolization or surgical clipping, once daily, for a minimum of 10 consecutive days and a maximum of 14 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Aspirin Group | Experimental | Patients receive 100 mg aspirin once daily, initiated within 48 hours of undergone successful aneurysm securing and continued for not less than 10 consecutive days and not more than 14 consecutive days, plus standard care. Receives: Drug: Aspirin |
| Placebo Control Group | Placebo comparator | Patients receive identical-appearing placebo capsules once daily, initiated within 48 hours of undergone successful aneurysm securing and continued for not less than 10 consecutive days and not more than 14 consecutive days, plus standard care. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with mRS 0-2 at 90 days after randomization
The proportion of patients with modified Rankin Scale (mRS) scores ranging from 0 to 2 at 90 days after randomization.
Measured: 90 days after randomization
Secondary outcomes (15)
Extended Glasgow Outcome Scale (eGOS) at 90 days
Functional prognosis assessed by Extended Glasgow Outcome Scale (eGOS) at 90 days after randomization.
Measured: 90 days after randomization
Ordinal shift analysis of mRS at 90 days (mRS 5 and 6 combined)
Ordinal shift analysis of modified Rankin Scale scores at 90 days after randomization, with mRS grade 5 and 6 merged into one category.
Measured: 90 days after randomization
Proportion of patients with mRS 0-3 at 90 days
Proportion of patients with modified Rankin Scale scores of 0 to 3 at 90 days after randomization.
Measured: 90 days after randomization
Mini-Mental State Examination (MMSE) score at 90 days
Cognitive function assessed via Mini-Mental State Examination (MMSE) scale.
Measured: 90 days after randomization
Extended Glasgow Outcome Scale (eGOS) at 1 year
Functional outcome assessed by Extended Glasgow Outcome Scale at 1 year after randomization.
Measured: 1 year after randomization.
Ordinal shift analysis of mRS at 1 year (mRS 5 and 6 combined)
Ordinal shift analysis of modified Rankin Scale scores at 1 year after randomization, combining mRS 5 and mRS 6 into a single category.
Measured: 1 year after randomization
Proportion of mRS 0-2 at 1 year
Proportion of patients with modified Rankin Scale scores of 0 to 2 at 1 year after randomization.
Measured: 1 year after randomization.
Proportion of patients with mRS 0-3 at 1 year
Percentage of subjects achieving modified Rankin Scale scores from 0 to 3 at one year after randomization.
Measured: 1 year after randomization.
Mini-Mental State Examination (MMSE) score at 1 year
Cognitive function evaluated by Mini-Mental State Examination (MMSE) scale.
Measured: 1 year after randomization
Change in NIHSS score from baseline at discharge
Changes in National Institutes of Health Stroke Scale (NIHSS) scores at discharge compared with baseline levels.
Measured: 30 days/discharge, which ever is earlier
Incidence of clinical delayed cerebral ischemia at discharge
Incidence rate of clinical delayed cerebral ischemia (DCI) observed at hospital discharge.
Measured: 30 days/discharge, which ever is earlier
Percentage of radiological DCI on CT/MRI at discharge
Proportion of patients with radiological delayed cerebral ischemia confirmed by cranial CT or MRI at hospital discharge.
Measured: 30 days/discharge, which ever is earlier
Lesion volume of radiological DCI on CT/MRI at discharge
Volume of lesions consistent with radiological delayed cerebral ischemia detected by cranial CT or MRI at hospital discharge.
Measured: 30 days/discharge, which ever is earlier
Incidence of invasive interventions
Incidence of invasive interventions including DSA and angioplasty performed during hospitalization.
Measured: 30 days/discharge, which ever is earlier
Rate of cerebrospinal fluid shunt surgery within 3 months
Proportion of patients receiving cerebrospinal fluid shunt surgery within 3 months after randomization.
Measured: Within 3 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completionMay 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid Hemorrhage (aSAH)Studies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, parallel-group study. Eligible patients with aSAH will be assigned to either the aspirin intervention group or the placebo control group in a 1:1 ratio.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 388 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganzhou City People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Wannan Medical College, Nanfang Hospital, Southern Medical University, Second Affiliated Hospital of Guangzhou Medical University, Affiliated Hospital of Guangdong Medical University, Fifth Affiliated Hospital of Guangzhou Medical University, Meizhou People's Hospital, Guizhou Provincial People's Hospital, The First Affiliated Hospital of Nanchang University, Jiangxi Provincial People's Hopital, Huang Shan People's Hospital, Jiujiang No.1 People's Hospital, Jinan Central Hospital, Yichun People's Hospital
- Responsible party
- Sponsor
- Investigators
- QiuHua Jiang, MD. PhD., Principal investigator, Ganzhou People's Hospital, Ganzhou, Jiangxi Province, ChinaZeguang Ren, MD. PhD., Principal investigator, Houston Methodist, Houston, USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07642427
- Sponsor's protocol ID
- GZPH-PJB2025-420-01
- Acronym
- aSAH-ASA
- Status last verified
- Jun 2026
- First submitted
- 28 May 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) cannot be shared due to patient privacy requirements, institutional policies, and legal and regulatory restrictions.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Efficacy and Safety of Early Prophylactic Use of Aspirin in Improving Prognosis of Patients With Aneurysmal Subarachnoid Hemorrhage: A Multicenter, Prospective, Double-Blind, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07642427
- Acronym / sponsor ID
- aSAH-ASA / GZPH-PJB2025-420-01
- Keywords
- Aneurysmal subarachnoid hemorrhage, Aspirin, Delayed cerebral ischemia, Antiplatelet therapy, Functional outcome, Randomized controlled trial
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Ganzhou City People's HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Wannan Medical College, Nanfang Hospital, Southern Medical University, Second Affiliated Hospital of Guangzhou Medical University, Affiliated Hospital of Guangdong Medical University, Fifth Affiliated Hospital of Guangzhou Medical University, Meizhou People's Hospital, Guizhou Provincial People's Hospital, The First Affiliated Hospital of Nanchang University, Jiangxi Provincial People's Hopital, Huang Shan People's Hospital, Jiujiang No.1 People's Hospital, Jinan Central Hospital, Yichun People's Hospital
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- May 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 11 Jun 2026 (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 study is a multicenter, prospective, double-blind, randomized controlled trial designed to evaluate whether early prophylactic use of aspirin improves functional outcomes in patients with aneurysmal subarachnoid hemorrhage (aSAH). Patients with aSAH who have undergone successful aneurysm securing will be randomly assigned to receive either aspirin plus standard care or a placebo plus standard care. The study drug will be started within 48 hours of undergone successful aneurysm securing and continued for not less than 10 days and not more than 14 consecutive days. The main goal is to compare the rate of favorable functional outcomes at 3 months between the two groups. Secondary goals include evaluating the incidence of delayed cerebral ischemia, cerebral infarction, mortality, and safety outcomes such as major bleeding events.
Detailed description
Aneurysmal subarachnoid hemorrhage (aSAH) is a life-threatening neurological emergency associated with high rates of morbidity and mortality. Delayed cerebral ischemia (DCI) and subsequent cerebral infarction are major contributors to poor functional outcomes in survivors. Antiplatelet agents such as aspirin have been hypothesized to reduce the risk of microthrombosis and DCI, but evidence for their early prophylactic use in aSAH remains limited and controversial. This trial aims to investigate the efficacy and safety of early aspirin administration in improving long-term functional outcomes in aSAH patients. Eligible patients will be randomized into two groups: the intervention group will receive 100 mg of oral aspirin daily for not less than 10 days and not more than 14 consecutive days, while the control group will receive an identical placebo. All patients in both groups will receive standardized aSAH management according to current clinical guidelines, including nimodipine, blood pressure control, and supportive care. The primary endpoint is the functional outcome measured by the modified Rankin Scale (mRS) at 3 months. Secondary endpoints include incidence of clinical DCI at discharge, percentage of imaging DCI detected on CT/MRI at discharge, all-cause mortality at 3 months, and safety outcomes including major bleeding events.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, parallel-group study. Eligible patients with aSAH will be assigned to either the aspirin intervention group or the placebo control group in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Aspirin Group | Experimental | Drug: AspirinPatients receive 100 mg aspirin once daily, initiated within 48 hours of undergone successful aneurysm securing and continued for not less than 10 consecutive days and not more than 14 consecutive days, plus standard care. |
| Placebo Control Group | Placebo comparator | Drug: PlaceboPatients receive identical-appearing placebo capsules once daily, initiated within 48 hours of undergone successful aneurysm securing and continued for not less than 10 consecutive days and not more than 14 consecutive days, plus standard care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years and ≤ 80 years.
- Spontaneous subarachnoid hemorrhage (SAH) confirmed by non-contrast head CT.
- Diagnosis of ruptured intracranial aneurysm confirmed, and successfully treated by either surgical clipping or endovascular coiling within 48 hours of ictus.
- Hunt-Hess grade ≤ 4 or WFNS grade ≤ 4 (assessed within 48 hours of SAH onset).
- Fisher grade 2-4 or modified Fisher grade 1-4.
Key exclusion criteria (28 listed)
- Hunt-Hess grade 5 or WFNS grade 5 (assessed within 48 hours of SAH onset).
- Patients requiring any intracranial stent or non-embolic intrasaccular device during aneurysm embolization, with post-procedural need for antiplatelet therapy.
- Angiogram-negative SAH.
- Note: Prior history of ruptured intracranial aneurysm or re-rupture of previously treated aneurysm is not excluded.
- Moderate-to-severe vasospasm demonstrated on pre-operative or intra-operative CTA/DSA in the emergency setting.
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 |
|---|---|---|
| AspirinAspirin 100 mg (1 tablet) administered orally, via nasogastric tube, or rectally within 48 hours after aneurysm embolization or surgical clipping, once daily, for a minimum of 10 consecutive days and a maximum of 14 consecutive days. | Drug | Aspirin Group |
| PlaceboPlacebo 1 tablet (identical in appearance to aspirin 100 mg) administered orally, via nasogastric tube, or rectally within 48 hours after aneurysm embolization or surgical clipping, once daily, for a minimum of 10 consecutive days and a maximum of 14 consecutive days. | Drug | Placebo Control Group |
Primary outcome
Proportion of patients with mRS 0-2 at 90 days after randomization
Time frame: 90 days after randomization
The proportion of patients with modified Rankin Scale (mRS) scores ranging from 0 to 2 at 90 days after randomization.
15 secondary outcomes
Extended Glasgow Outcome Scale (eGOS) at 90 days
Time frame: 90 days after randomization
Ordinal shift analysis of mRS at 90 days (mRS 5 and 6 combined)
Time frame: 90 days after randomization
Proportion of patients with mRS 0-3 at 90 days
Time frame: 90 days after randomization
Mini-Mental State Examination (MMSE) score at 90 days
Time frame: 90 days after randomization
Extended Glasgow Outcome Scale (eGOS) at 1 year
Time frame: 1 year after randomization.
Ordinal shift analysis of mRS at 1 year (mRS 5 and 6 combined)
Time frame: 1 year after randomization
Proportion of mRS 0-2 at 1 year
Time frame: 1 year after randomization.
Proportion of patients with mRS 0-3 at 1 year
Time frame: 1 year after randomization.
Mini-Mental State Examination (MMSE) score at 1 year
Time frame: 1 year after randomization
Change in NIHSS score from baseline at discharge
Time frame: 30 days/discharge, which ever is earlier
Incidence of clinical delayed cerebral ischemia at discharge
Time frame: 30 days/discharge, which ever is earlier
Percentage of radiological DCI on CT/MRI at discharge
Time frame: 30 days/discharge, which ever is earlier
Lesion volume of radiological DCI on CT/MRI at discharge
Time frame: 30 days/discharge, which ever is earlier
Incidence of invasive interventions
Time frame: 30 days/discharge, which ever is earlier
Rate of cerebrospinal fluid shunt surgery within 3 months
Time frame: Within 3 months after randomization
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 11 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) cannot be shared due to patient privacy requirements, institutional policies, and legal and regulatory restrictions.
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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.
QiuHua Jiang, MD. PhD. principal investigator
Ganzhou People's Hospital, Ganzhou, Jiangxi Province, China
Zeguang Ren, MD. PhD. principal investigator
Houston Methodist, Houston, USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Aspirin in people with Aneurysmal Subarachnoid Hemorrhage (aSAH) and Delayed Cerebral Ischemia, run by Ganzhou City People's Hospital 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 7 inclusion and 28 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 11 Jun 2026. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Weilong Huang, MD. PhD. (+8618807971121, doctorhwl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with mRS 0-2 at 90 days after randomization (time frame: 90 days after randomization). 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 11 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.