Brain DiseasesPhase 3IRIS-sICASNCT06447701
Interleukin-6 Receptor Inhibition for Symptomatic Intracranial Atherosclerosis
A Phase 3 study testing Tocilizumab and NaCl 0.9% 100ml in people with Brain Diseases and Ischemic Stroke, run by Zhujiang Hospital.
Trial summary
IRIS-sICAS is a multicenter, randomized, double-blind, placebo-controlled clinical trialis a multicenter, randomized, double-blind, placebo-controlled clinical trial, to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Diseases, Ischemic Stroke, Ischemia
- What is being tested?
- Tocilizumab and NaCl 0.9% 100ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 486 participants
- Where
- No sites listed yet
- Study dates
- 30 Oct 2025to 30 Jun 2029
- 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
- Male or non-pregnant women with acute stroke symptoms aged over 18 years.
- Patients having an ischemic stroke or a TIA prior to randomization (Patients having an acute ischemic stroke within 72 hours with NIHSS score≤5 at baseline, or patients having a TIA within 72 hours with Oxfordshire Community Stroke Project on the basis of age, blood pressure, clinical features, and duration of TIA symptoms (ABCD2) score≥4 at baseline).
- The entry event is attributed to symptomatic atherosclerosis (50-99%) in an intracranial qualifying artery (intracranial carotid artery (C4-7), middle cerebral artery (M1), intracranial vertebral artery or basilar artery) confirmed by CT, MR angiography, or digital subtraction angiography.
- Informed consent obtained from patients or their legal representatives.
- Willing to be followed up as required by the clinical study protocol.
Who cannot join
- Thrombolytic therapy or thrombectomy within 24 hours prior to enrollment.
- Pre-stroke mRS score ≥ 2.
- Combined or previous intracranial hemorrhage: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
- Any of the following unequivocal cardiac source of embolism: chronic or paroxysmal atrial fibrillation, sinus node dysfunction, mitral stenosis, prosthetic heart valves, endocarditis, left ventricular mural thrombus or valvular vegetation, myocardial infarction within three months, dilated cardiomyopathy, spontaneous echogenic defects in the left atrium or an ejection fraction of less than 30%.
- Intracranial arterial stenosis due to arterial dissection, Moya Moya disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus; any known vasculitic disease.
- Extracranial stenosis ≥50%, subclavian arterial stenosis≥50% or subclavian steal syndrome.
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- Previous interventions for intracranial arterial stenosis.
- Concurrent intracranial tumors, intracranial aneurysms or arteriovenous malformations
- Neutrophil < 2×10 9/L.
- Platelet < 100×10 9/L.
- Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than 1.5 times the upper limit of normal.
- Active infections including localized.
- Evidence of HIV or hepatitis B positivity.
- Positive tuberculosis-related tests.
- Concurrent peptic ulcer, diverticulitis or inflammatory bowel disease.
- Concurrent malignant tumors, recent bone marrow transplant or recent organ transplant.
- Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg despite blood pressure control.
- Known allergy to tocilizumab or excipients.
- Use of immunosuppressive drugs or systemic use of antibiotics.
- Received any live or live attenuated vaccine within 4 weeks prior to enrollment or plan to receive a live or live attenuated vaccine during the study.
- History of demyelination or presence of neurological symptoms suggestive of demyelination.
- Previously existing neurological or psychiatric disorders that could potentially confuse neurological function assessment.
- An expected survival less than 90 days.
- Participation in another interventional clinical study.
- Patients unsuitable for enrollment in the clinical trial according to investigators decision making.
About this study
Official title: Effect of Interleukin-6 Receptor Inhibition for Avoiding Recurrence of Ischemic Stroke in Patients With Symptomatic Intracranial Atherosclerosis: a Double-blind, Randomized, Placebo-controlled Trial
IRIS-sICAS is a multicenter, randomized, double-blind, placebo-controlled clinical trialis a multicenter, randomized, double-blind, placebo-controlled clinical trial, to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis in symptomatic intracranial atherosclerosis patients.
Read the detailed description
Intracranial atherosclerosis (ICAS) is one of the most common causes of stroke worldwide, and the currently recommended intensive pharmacologic and surgical treatments show only modest efficacy, with approximately 20% of strokes still recurring, for which there is no targeted treatment. Tocilizumab is a recombinant humanized anti-human interleukin-6 receptor monoclonal antibody that exerts anti-inflammatory effects by specifically binding to the IL-6 receptor and blocking IL-6 signal transduction. Previous studies have shown that tocilizumab can effectively attenuate acute ischemic injury in the early stage of myocardial infarction and has potentially anti-atherosclerotic effects. However, application in ICAS not yet reported. This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial, which enrolled patients with symptomatic ICAS occurring within 72 hours of ischemic stroke or high-risk transient ischemic attack. Patients who consented to participate in the study were randomly assigned in a 1:1 ratio to receive a single infusion of 320mg tocilizumab or placebo (saline injection), and patients were followed up to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis.
- Conditions
- Brain Diseases, Ischemic Stroke, Ischemia, Stroke, Cerebral Infarction, Atherosclerosis of Artery
- Being tested
- Tocilizumab, NaCl 0.9% 100ml
- Keywords
- Tocilizumab, Symptomatic intracranial atherosclerotic stenosis, Recurrence, Ischemic stroke
- Medical subject headings
- Brain Diseases, Ischemic Stroke, Ischemia, Stroke, Cerebral Infarction, Intracranial Arteriosclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Single dose intravenous application
NaCl 0.9% 100mlDrug
Single dose intravenous application
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab group | Experimental | Intravenously for more than 1 hour. Receives: Drug: Tocilizumab |
| Control group | Placebo comparator | Intravenously for more than 1 hour. Receives: Drug: NaCl 0.9% 100ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with newly diagnosed ischemic stroke within 90(±7) days
Stroke is defined as an acute episode of focal neurological dysfunction associated with cerebral vascular injury, with no apparent non-vascular cause such as brain infection, trauma, tumor, seizure, severe metabolic disease, or degenerative neurological disease.
Ischemic stroke is defined as an acute episode of a new focal neurological deficit lasting >24 hours, an increase in existing focal neurological deficit lasting >24 hours, or a focal neurological deficit lasting <24 hours that is associated with evidence of new ischemic changes based on neuroimaging. The focal neurological deficit is not attributable to a non-ischemic etiology. Hemorrhage may be a consequence of ischemic stroke, and in this situation, the stroke is an ischemic stroke with hemorrhagic transformation but not a hemorrhagic stroke.
Measured: 90(±7) days
Secondary outcomes (9)
The functional neurological status at 6(±1) days or discharge if earlier from baseline
The functional neurological status is evaluated through National Institute of Health Stroke Scale(NIHSS). The NIHSS is a standardized neurological examination score that is a valid and reliable measure of disability and recovery after acute stroke. Scores range from 0 to 42, with higher scores indicating more severe disability. The scale includes measures of level of consciousness, extra ocular movements, motor and sensory tests, coordination, language and speech evaluations.
Measured: 6(±1) days
The incidence of composite events including any type of stroke (ischemic stroke(IS), subarachnoid hemorrhage(SAH), or intracerebral hemorrhage(ICH)), myocardial infarction(MI), and transient ischemic attack(TIA) and each of foresaid events at 30(±3) days
IS is defined as an acute episode of a new focal neurological deficit lasting >24 hrs, an increase in existing focal neurological deficit lasting >24 hrs, or a focal neurological deficit lasting <24 hrs that is associated with evidence of new ischemic changes based on neuroimaging. The focal neurological deficit is unrelated to a non-ischemic etiology. Hemorrhage may be a result of IS.
Hemorrhagic stroke including SAH and ICH is defined as a new focal neurological deficit caused by a nontraumatic intraparenchymal hemorrhage, with neuroimaging evidence of corresponding intraparenchymal hemorrhage, except hemorrhagic transformation of an IS.
MI is defined as an episode of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
TIA is defined as a transient episode of a focal ischemic neurological deficit resolving completely within 24 hrs, caused by focal cerebral or retinal ischemia, without evidence of corresponding cerebral infarction based on neuroimaging.
Measured: 30(±3) days
The incidence of composite events including any type of stroke (ischemic stroke(IS), subarachnoid hemorrhage(SAH), or intracerebral hemorrhage(ICH)), myocardial infarction(MI), and transient ischemic attack(TIA) and each of foresaid events at 90(±7) days
IS is defined as an acute episode of a new focal neurological deficit lasting >24 hrs, an increase in existing focal neurological deficit lasting >24 hrs, or a focal neurological deficit lasting <24 hrs that is associated with evidence of new ischemic changes based on neuroimaging. The focal neurological deficit is unrelated to a non-ischemic etiology. Hemorrhage may be a result of IS.
Hemorrhagic stroke including SAH and ICH is defined as a new focal neurological deficit caused by a nontraumatic intraparenchymal hemorrhage, with neuroimaging evidence of corresponding intraparenchymal hemorrhage, except hemorrhagic transformation of an IS.
MI is defined as an episode of myocardial necrosis in a clinical setting consistent with myocardial ischemia.
TIA is defined as a transient episode of a focal ischemic neurological deficit resolving completely within 24 hrs, caused by focal cerebral or retinal ischemia, without evidence of corresponding cerebral infarction based on neuroimaging.
Measured: 90(±7) days
Proportion of patients with functional independence at 90(±7) days
Functional independence is defined as the modified Rankin Scale(mRS) score ranging from 0-2.
The mRS is a valid and reliable clinician-reported measure of global disability that has been widely applied for evaluating recovery from stroke. It is a scale used to measure functional recovery (the degree of disability or dependence in daily activities) of people who have suffered a stroke. mRS scores range from 0 to 6, with 0 indicating no residual symptoms; 5 indicating bedbound, requiring constant care; and 6 indicating death.
Measured: 90(±7) days
Health-related quality of life at 90(±7) days
Health-related quality of life is assessed with the European Quality Five Dimensions Five Level scale (EQ-5D-5L).
The EQ-5D-5L is a generic instrument for describing and valuing health. It is based on a descriptive system that defines health in terms of five dimensions: Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression. Each dimension has five response categories corresponding to: no problems, slight, moderate, severe and extreme problems. The instrument is designed for self-completion, and respondents also rate their overall health on the day of the interview on a 0-100 hash-marked, vertical visual analogue scale.
Measured: 90(±7) days
Mortality at 90(±7) days
Mortality rates are defined as the number of deaths observed divided by the number of subjects observed over the 90-day study period.
Measured: 90(±7) days
Incidence of serious adverse events
Including but not limited to acute respiratory failure, severe or malignant cerebral artery infarction, acute heart failure, debridement decompression, and other major medical events that can result in death, immediately life-threatening, hospitalization or prolongation of this hospitalization, terminally or severely disabling/incapacitating, the loss of a significant ability to maintain normal life functioning, or medical intervention to avoid the above outcomes.
Measured: 90(±7) days
Change of inflammatory blood biomarkers from admission to 72 hours
Interleukin-6 (IL-6)
Measured: 72 hours
Change of inflammatory blood biomarkers from admission to 72 hours
hypersensitive C-reactive protein (hsCRP)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start30 Oct 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DiseasesStudies of the same condition, open and under way.
- More trials run by Zhujiang 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. Investigators, other blinded investigators, subjects, and sponsors will not have access to any information regarding group assignment or related documents pertaining to the trial drug.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, Central People's Hospital of Zhanjiang, Shantou Central Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, Guangzhou First People's Hospital, Peking University Shenzhen Hospital, Guangdong Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06447701
- Sponsor's protocol ID
- LC2024ZD025
- Acronym
- IRIS-sICAS
- Status last verified
- Jul 2025
- First submitted
- 3 Jun 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Interleukin-6 Receptor Inhibition for Avoiding Recurrence of Ischemic Stroke in Patients With Symptomatic Intracranial Atherosclerosis: a Double-blind, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06447701
- Acronym / sponsor ID
- IRIS-sICAS / LC2024ZD025
- Conditions
- Brain Diseases, Ischemic Stroke, Ischemia, Stroke, Cerebral Infarction, Atherosclerosis of Artery
- Keywords
- Tocilizumab, Symptomatic intracranial atherosclerotic stenosis, Recurrence, Ischemic stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, Central People's Hospital of Zhanjiang, Shantou Central Hospital, Eighth Affiliated Hospital, Sun Yat-sen University, Guangzhou First People's Hospital, Peking University Shenzhen Hospital, Guangdong Provincial People's Hospital
- Study start
- 30 Oct 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 7 Jun 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.
IRIS-sICAS is a multicenter, randomized, double-blind, placebo-controlled clinical trialis a multicenter, randomized, double-blind, placebo-controlled clinical trial, to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis in symptomatic intracranial atherosclerosis patients.
Detailed description
Intracranial atherosclerosis (ICAS) is one of the most common causes of stroke worldwide, and the currently recommended intensive pharmacologic and surgical treatments show only modest efficacy, with approximately 20% of strokes still recurring, for which there is no targeted treatment. Tocilizumab is a recombinant humanized anti-human interleukin-6 receptor monoclonal antibody that exerts anti-inflammatory effects by specifically binding to the IL-6 receptor and blocking IL-6 signal transduction. Previous studies have shown that tocilizumab can effectively attenuate acute ischemic injury in the early stage of myocardial infarction and has potentially anti-atherosclerotic effects. However, application in ICAS not yet reported. This study is a multicenter, randomized, double-blind, placebo-controlled clinical trial, which enrolled patients with symptomatic ICAS occurring within 72 hours of ischemic stroke or high-risk transient ischemic attack. Patients who consented to participate in the study were randomly assigned in a 1:1 ratio to receive a single infusion of 320mg tocilizumab or placebo (saline injection), and patients were followed up to assess the safety and efficacy of tocilizumab injection in lowering the incidence of newly diagnosis ischemic stroke and improving prognosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The subject numbers and corresponding medication numbers are permanently identified and unique for each successfully randomized patient. If any patients who have been successfully randomized do not receive the trial medication or cannot be reassigned to others, their medication and medication numbers will be invalidated by the medication administrator. To ensure blinding during the trial execution, unblinded personnel responsible for administering and configuring the trial drug must sign a confidentiality agreement. Investigators, other blinded investigators, subjects, and sponsors will not have access to any information regarding group assignment or related documents pertaining to the trial drug.
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab group | Experimental | Drug: TocilizumabIntravenously for more than 1 hour. |
| Control group | Placebo comparator | Drug: NaCl 0.9% 100mlIntravenously for more than 1 hour. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or non-pregnant women with acute stroke symptoms aged over 18 years.
- Patients having an ischemic stroke or a TIA prior to randomization (Patients having an acute ischemic stroke within 72 hours with NIHSS score≤5 at baseline, or patients having a TIA within 72 hours with Oxfordshire Community Stroke Project on the basis of age, blood pressure, clinical features, and duration of TIA symptoms (ABCD2) score≥4 at baseline).
- The entry event is attributed to symptomatic atherosclerosis (50-99%) in an intracranial qualifying artery (intracranial carotid artery (C4-7), middle cerebral artery (M1), intracranial vertebral artery or basilar artery) confirmed by CT, MR angiography, or digital subtraction angiography.
- Informed consent obtained from patients or their legal representatives.
- Willing to be followed up as required by the clinical study protocol.
Key exclusion criteria (25 listed)
- Thrombolytic therapy or thrombectomy within 24 hours prior to enrollment.
- Pre-stroke mRS score ≥ 2.
- Combined or previous intracranial hemorrhage: hemorrhagic stroke, epidural hematoma, subdural hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
- Any of the following unequivocal cardiac source of embolism: chronic or paroxysmal atrial fibrillation, sinus node dysfunction, mitral stenosis, prosthetic heart valves, endocarditis, left ventricular mural thrombus or valvular vegetation, myocardial infarction within three months, dilated cardiomyopathy, spontaneous echogenic defects in the left atrium or an ejection fraction of less than 30%.
- Intracranial arterial stenosis due to arterial dissection, Moya Moya disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; post-partum angiopathy; suspected vasospastic process, suspected recanalized embolus; any known vasculitic disease.
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 |
|---|---|---|
| TocilizumabSingle dose intravenous application | Drug | Tocilizumab group |
| NaCl 0.9% 100mlSingle dose intravenous application | Drug | Control group |
Primary outcome
The proportion of patients with newly diagnosed ischemic stroke within 90(±7) days
Time frame: 90(±7) days
Stroke is defined as an acute episode of focal neurological dysfunction associated with cerebral vascular injury, with no apparent non-vascular cause such as brain infection, trauma, tumor, seizure, severe metabolic disease, or degenerative neurological disease. Ischemic stroke is defined as an acute episode of a new focal neurological deficit lasting >24 hours, an increase in existing focal neurological deficit lasting >24 hours, or a focal neurological deficit lasting <24 hours that is associated with evidence of new ischemic changes based on neuroimaging. The focal neurological deficit is not attributable to a non-ischemic etiology. Hemorrhage may be a consequence of ischemic stroke, and in this situation, the stroke is an ischemic stroke with hemorrhagic transformation but not a hemorrhagic stroke.
9 secondary outcomes
The functional neurological status at 6(±1) days or discharge if earlier from baseline
Time frame: 6(±1) days
The incidence of composite events including any type of stroke (ischemic stroke(IS), subarachnoid hemorrhage(SAH), or intracerebral hemorrhage(ICH)), myocardial infarction(MI), and transient ischemic attack(TIA) and each of foresaid events at 30(±3) days
Time frame: 30(±3) days
The incidence of composite events including any type of stroke (ischemic stroke(IS), subarachnoid hemorrhage(SAH), or intracerebral hemorrhage(ICH)), myocardial infarction(MI), and transient ischemic attack(TIA) and each of foresaid events at 90(±7) days
Time frame: 90(±7) days
Proportion of patients with functional independence at 90(±7) days
Time frame: 90(±7) days
Health-related quality of life at 90(±7) days
Time frame: 90(±7) days
Mortality at 90(±7) days
Time frame: 90(±7) days
Incidence of serious adverse events
Time frame: 90(±7) days
Change of inflammatory blood biomarkers from admission to 72 hours
Time frame: 72 hours
Change of inflammatory blood biomarkers from admission to 72 hours
Time frame: 72 hours
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 28 Jul 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab and NaCl 0.9% 100ml in people with Brain Diseases and Ischemic Stroke, run by Zhujiang 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 5 inclusion and 25 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 28 Jul 2025. 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 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?
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?
The proportion of patients with newly diagnosed ischemic stroke within 90(±7) days (time frame: 90(±7) days). 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 28 Jul 2025.