Acute Ischemic StrokePhase 3NCT07105917
SLGT2i for Neuroprotection in Patients With Acute Ischemic Stroke
A Phase 3 study testing SGLT-2 inhibitors and Standard medical treatment in people with Acute Ischemic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial summary
Stroke is a leading cause of disability and mortality globally. With population aging, ischemic stroke (80% of cases) has become China's primary cause of adult disability. Sodium-dependent glucose transporters 2 inhibitors （SGLT2i） demonstrate cardiovascular protection beyond glycemic control, even in patients without… 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?
- SGLT-2 inhibitors and Standard medical treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,050 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 1 Nov 2026
- 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
- Age ≥ 18 years
- Patients with acute ischemic stroke (AIS) within ≤ 3 days of onset, with no restrictions on reperfusion therapy
- NIHSS score of 4-25 at the time of randomization
- Pre-stroke mRS score ≤ 1
- Signed informed consent form
Who cannot join
- Presence of intracranial hemorrhage at the time of randomization
- BMI ≤ 18 kg/m²
- Severe renal insufficiency (eGFR < 30 mL/min) or severe liver impairment (Child-Pugh Class C liver function)
- Type 1 diabetes mellitus
- Blood glucose level < 2.7 mmol/L or > 22.2 mmol/L at the time of randomization
- Systolic blood pressure < 95 mmHg at the time of randomization
Show all 13Show fewer
- History of heart failure
- Use of SGLT-2 inhibitors within 4 weeks prior to randomization
- Intolerance to SGLT-2 inhibitors
- Life expectancy < 3 months
- Pregnant or lactating women
- Already enrolled in another clinical trial
- Other conditions deemed inappropriate for inclusion by the investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sodium-dependent Glucose Transporters 2 Inhibitor for Neuroprotection in Patients With Acute Ischemic Stroke
Stroke is a leading cause of disability and mortality globally. With population aging, ischemic stroke (80% of cases) has become China's primary cause of adult disability. Sodium-dependent glucose transporters 2 inhibitors （SGLT2i） demonstrate cardiovascular protection beyond glycemic control, even in patients without diabetes.
Preclinical studies suggest neuroprotective effects via improving cerebral glucose metabolism, anti-inflammatory/antioxidant actions, and reducing neuronal apoptosis. Therefore, the investigators aim to evaluate whether SGLT2i could improve 3-month functional outcomes (mRS scores) in AIS patients compared to standard care.
- Conditions
- Acute Ischemic Stroke
- Being tested
- SGLT-2 inhibitors, Standard medical treatment
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGLT-2 inhibitorsDrug
Any of the following SGLT2 inhibitors (SGLT2i) can be selected for treatment:
Dapagliflozin 10 mg once daily (QD) or Empagliflozin 10 mg once daily (QD) If the patient has concurrent diabetes, the use of other antidiabetic drugs is not restricted.
The treatment should last for at least 14 days.
Standard medical treatmentOther
According to the guideline-recommended standard treatment, if the patient has diabetes, there is no restriction on the use of other antidiabetic drugs (except SGLT-2 inhibitors).
| Study group | Role | What they receive |
|---|---|---|
| Experimental: SGLT2i with standard therapy | Experimental | Any of the following SGLT2 inhibitors (SGLT2i) can be selected for treatment:
Dapagliflozin 10 mg once daily (QD) or Empagliflozin 10 mg once daily (QD) If the patient has concurrent diabetes, the use of other antidiabetic drugs is not restricted.
The treatment should last for at least 14 days. Receives: Drug: SGLT-2 inhibitors |
| Standard therapy | Sham comparator | According to the guideline-recommended standard treatment, if the patient has diabetes, there is no restriction on the use of other antidiabetic drugs (except SGLT-2 inhibitors). Receives: Other: Standard medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of mRS scores at 3 months
Measured: 3 months
Secondary outcomes (12)
Proportion of patients with mRS scores 0-1 at 3 months
Measured: 90 days
Proportion of patients with mRS scores 0-2 at 3 months
Measured: 90 days
Proportion of patients with mRS scores 0-3 at 3 months
Measured: 90 days
NIHSS scores at Day 7 post-onset/at discharge
Measured: 7 days
Change in NIHSS scores from randomization to Day 7 post-onset/at discharge
Measured: 7 days
All-cause mortality
Measured: 90 days
Stroke-related mortality
Measured: 90 days
Symptomatic intracranial hemorrhage within 14 days
Measured: 14 days
Early neurological deterioration, defined as an increase of ≥4 points in NIHSS scores from randomization to Day 7 post-onset/at discharge
Measured: 7 days
Serious adverse events within 3 months
Measured: 90 days
Adverse events leading to discontinuation of SGLT2i
Measured: 14 days
Adverse events related to SGLT2i (volume depletion, renal events, severe hypoglycemic events, fractures, diabetic ketoacidosis, amputations)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,050 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Min Lou, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07105917
- Sponsor's protocol ID
- SNPS
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 11 Aug 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium-dependent Glucose Transporters 2 Inhibitor for Neuroprotection in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT07105917
- Acronym / sponsor ID
- SNPS
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 6 Aug 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.
Stroke is a leading cause of disability and mortality globally. With population aging, ischemic stroke (80% of cases) has become China's primary cause of adult disability. Sodium-dependent glucose transporters 2 inhibitors （SGLT2i） demonstrate cardiovascular protection beyond glycemic control, even in patients without diabetes.
Preclinical studies suggest neuroprotective effects via improving cerebral glucose metabolism, anti-inflammatory/antioxidant actions, and reducing neuronal apoptosis. Therefore, the investigators aim to evaluate whether SGLT2i could improve 3-month functional outcomes (mRS scores) in AIS patients compared to standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: SGLT2i with standard therapy | Experimental | Drug: SGLT-2 inhibitorsAny of the following SGLT2 inhibitors (SGLT2i) can be selected for treatment: Dapagliflozin 10 mg once daily (QD) or Empagliflozin 10 mg once daily (QD) If the patient has concurrent diabetes, the use of other antidiabetic drugs is not restricted. The treatment should last for at least 14 days. |
| Standard therapy | Sham comparator | Other: Standard medical treatmentAccording to the guideline-recommended standard treatment, if the patient has diabetes, there is no restriction on the use of other antidiabetic drugs (except SGLT-2 inhibitors). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patients with acute ischemic stroke (AIS) within ≤ 3 days of onset, with no restrictions on reperfusion therapy
- NIHSS score of 4-25 at the time of randomization
- Pre-stroke mRS score ≤ 1
- Signed informed consent form
Key exclusion criteria (13 listed)
- Presence of intracranial hemorrhage at the time of randomization
- BMI ≤ 18 kg/m²
- Severe renal insufficiency (eGFR < 30 mL/min) or severe liver impairment (Child-Pugh Class C liver function)
- Type 1 diabetes mellitus
- Blood glucose level < 2.7 mmol/L or > 22.2 mmol/L at the time of randomization
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 |
|---|---|---|
| SGLT-2 inhibitorsAny of the following SGLT2 inhibitors (SGLT2i) can be selected for treatment: Dapagliflozin 10 mg once daily (QD) or Empagliflozin 10 mg once daily (QD) If the patient has concurrent diabetes, the use of other antidiabetic drugs is not restricted. The treatment should last for at least 14 days. | Drug | Experimental: SGLT2i with standard therapy |
| Standard medical treatmentAccording to the guideline-recommended standard treatment, if the patient has diabetes, there is no restriction on the use of other antidiabetic drugs (except SGLT-2 inhibitors). | Other | Standard therapy |
Primary outcome
Distribution of mRS scores at 3 months
Time frame: 3 months
12 secondary outcomes
Proportion of patients with mRS scores 0-1 at 3 months
Time frame: 90 days
Proportion of patients with mRS scores 0-2 at 3 months
Time frame: 90 days
Proportion of patients with mRS scores 0-3 at 3 months
Time frame: 90 days
NIHSS scores at Day 7 post-onset/at discharge
Time frame: 7 days
Change in NIHSS scores from randomization to Day 7 post-onset/at discharge
Time frame: 7 days
All-cause mortality
Time frame: 90 days
Stroke-related mortality
Time frame: 90 days
Symptomatic intracranial hemorrhage within 14 days
Time frame: 14 days
Early neurological deterioration, defined as an increase of ≥4 points in NIHSS scores from randomization to Day 7 post-onset/at discharge
Time frame: 7 days
Serious adverse events within 3 months
Time frame: 90 days
Adverse events leading to discontinuation of SGLT2i
Time frame: 14 days
Adverse events related to SGLT2i (volume depletion, renal events, severe hypoglycemic events, fractures, diabetic ketoacidosis, amputations)
Time frame: 90 days
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 Aug 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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing SGLT-2 inhibitors and Standard medical treatment in people with Acute Ischemic Stroke, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
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 13 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 Aug 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?
Contact Min Lou (+8615925622176, lm99@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of mRS scores at 3 months (time frame: 3 months). 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 Aug 2025.